Randomization Number A RandomizEd Trial of ENtERal Glutamine

Randomization Number A RandomizEd Trial of ENtERal Glutamine

Randomization Number A RandomizEd Trial of ENtERal Glutamine to MinimIZE Thermal Injury Clinical trials.gov ID #NCT00985205 electronic Case Report Form (eCRF) Worksheets and Instructions Please direct questions to: Maureen Dansereau Project Leader Tel: 613-549-6666 ext. 6686 Email: [email protected] 19 July 2017 1 Randomization Number Table of Contents Page # General Instructions 3 Central Randomization System (CRS) web address 4 Screening Inclusion 5 Screening Exclusion 7 Pre-randomization / Randomization 9 REDCap (Electronic Data Capture System) web address 11 Baseline 12 Comorbidities List 14 Organ Dysfunction 15 Invasive Mechanical Ventilation/ Renal Replacement Therapy 17 Study Intervention 19 Daily Monitoring 21 Laboratory

23 Nutrition Assessment/Timing 25 Daily Nutrition 27 Burn Related Operative Procedures 30 Concomitant Medications 32 Microbiology 34 Protocol Violation 36 Hospitalization Overview 38 - 41 Month 6 Survival Assessment 42 Month 6 Follow-up Assessments: Contact Log 44 Month 6 Follow-up Questionnaires 46 SF-36 Katz Index of Independence in Activities in Daily Living (ADL) Lawton Instrumental Activities of Daily Living (IADL) 47-51 52 53 - 54 Investigator Confirmation 55 Appendix 1: Lund-Browder Diagram 57 2 General Instructions The following case report form worksheets have been developed to assist the research coordinator at the participating site with data collection. The Research Coordinator (RC) may choose to record the data from the patients medical chart (source document) on these forms before entering the data in to the electronic data capture system i.e. REDCAP. The RC may choose to enter data into REDCap directly from the medical chart or use her/ his own worksheets. Whichever method is used, the instructions on each page that detail how and when the data is to be collected applies. Note: The appearance of these worksheets and the order in which they appear may vary slightly from REDCap. 1. To help you keep track, we recommend documenting the patient randomization number on each worksheet. 2. In this document, Acute Care Unit (ACU) is used to refer to both Intensive Care Units and Burn Units. 3. Date format will be year-month-day, entered as yyyy-mm-dd. For example, September 8th 2015 would be entered as: 2015-09-08 .

4. All times should be recorded using the 24 hour clock. Midnight is to be entered as 00:00 hrs. Unlike military time, the colon is required between the hour and the minutes. 5. Anywhere that 'Other (specify)' is selected, there must be an entry in REDCap (in the space provided) describing what Other' means. 6. Study days are defined as follows and data must be collected according to study days: Study Day 1 = ACU admit date (not randomization) and time until 23:59 the same day. Study Day 2 = the subsequent day starting at 00:00 to 23:59 that day Example: A patient is admitted to the ACU on Sept 8th, 2015 at 4:00 PM (16:00). The study days would be: Study Day 1 = 2015-09-08 from 16:00 to 23:59 the same date (2015-09-08) Study Day 2 = 2015-09-09 from 00:00 to 23:59 on 2015-09-09 (same date) 7. The duration of data collection and frequency will vary by form and is outlined as follows: To be collected once: Laboratory Units, Baseline, Organ Dysfunction, Hospitalization Overview, 6 Month Follow-up to include Survival Assessment, SF-36, ADL, and IADL. To be collected once and then additionally with each occurrence: Study Intervention, Nutrition Assessment/Timing To be collected daily from randomization until > 7 days post last successful grafting, or until ACU discharge, or 3 months from ACU admission, whichever comes first: Daily Monitoring (dose of study intervention received) To be collected daily until > 10 days post last successful grafting (stop of study intervention + 3 days), or until ACU discharge, or 3 months from ACU admission, whichever comes first: Concomitant Medications. To be collected daily from Study Day 1 through Study Day 14 and then once a week: Laboratory form. To be collected from Study Day 1 through Study Day 12: Daily Nutrition form including labs on the form. To be collected upon each occurrence: Burn Related Operative Procedures, Mechanical Ventilation, Renal Replacement Therapy, Microbiology (Gram-negative bacteremias), Protocol Violations, Serious Adverse Events Refer to specific instructions for each worksheet. 8. There may be occasions when data is unavailable, not applicable or not known. The measurement may not have been taken, the test not done, or the data may be missing from the source document. Example: T-Bilirubin was not done on a particular study day. If the data is 'Not Available' for any reason, indicate by selecting Not Available. 3 Central Randomization System (CRS) The following pages (4 - 10 inclusive) refer to the data to be entered into the Central Randomization System (CRS). Access the CRS at the following web address: https://ceru.hpcvl.queensu.ca/CRS/ Enter all patients who meet the Inclusion Criteria. 4 Randomization Number Screening - Inclusion Instructions Inclusion Criteria Only patients who meet the inclusion criteria should be entered into the Central Randomization System (CRS). Eligibility must be confirmed by the Site Investigator/or sub-Investigator before randomization can occur. 1. Presence of 2nd and/ The presence of deep 2nd and/or 3rd degree burns requiring grafting is an or 3rd degree assessment that must be confirmed by the SI or sub-I. burns requiring skin grafting The following burn injuries fulfill The following burn injuries do NOT this criteria fulfill this criteria Thermal burn injuries: Scald Fire (includes both Flame and Flash) Radiation Chemical Unknown Other, Specify__________________ 2. Patient meets one of the following 4 criteria:

Do NOT include injuries from any of the following: High voltage electrical contact (see exclusion #7.) Frostbite Stevens-Johnson Syndrome (SJS) Toxic Epidermal Necrolysis (TEN) This assessment must be confirmed by the SI or sub-I based on her/his clinical judgment. Check only one box to indicate which of the 4 criteria is met. Eligibility Requirements: a) Patients 18 - 39 years of age with TBSA burn > 20%. b) Patients 18 - 39 years of age with TBSA burn > 15% and with inhalation injury*. c) Patients 40 59 years of age with TBSA burn > 15% d) Patients > 60 years of age with TBSA burn > 10% Consent must be obtained within 72 hours of admission to the ACU. Refer to exclusion criteria for more details. 5 Randomization Number ScreeningInclusion Inclusion Criteria 1. Presence of Deep 2nd and/or Deep 3rd degree burns requiring grafting Yes No 2. Patient meets one of the following 4 criteria: a. Patients 18 - 39 years of age with TBSA burn 20% b. Patients 18 - 39 years of age with TBSA burn 15% WITH inhalation injury c. Patients 40 - 59 years of age with TBSA burn > 15% d. Patients > 60 years of age TBSA burn > 10% Yes No a. b. c. d. 6 Randomization Number Screening - Exclusion Instructions Record all exclusion criteria that the patient meets. If any one of the twelve criteria below are met, then the patient is NOT ELIGIBLE. 1. > 72 hours from admission to Acute Care Unit to time of consent This refers to admission to your ACU. If a patient is transferred from another facility, the clock starts from the time of admission to your unit. An exception would be a patient who has been at another facility for an extended period of time, post burn, prior to admission to your unit. 2. Patients younger than 18 years of age There is no upper age limit for enrollment in this study. 3. Renal Dysfunction: - In patients without known renal disease, renal dysfunction defined as a serum creatinine >171 mol/L or >1.93 mg/dL or a mol/L or >1.93 mg/dL or a urine output of less than 500 mL/last 24 hours (or 80 mL/last 4 hours if a 24 hour period of observation is not available). - In patients with acute or chronic renal failure (pre-dialysis), an absolute increase of >80 mol/L or >1.93 mg/dL or a mol/L or >0.9 mg/dL from baseline or pre-admission creatinine or a urine output of <500 mL/last 24 hours (or 80 mL/last 4 hours) will be required. - Patients with chronic renal failure on dialysis will be excluded. 4. Liver cirrhosis: Child-Pugh Class C liver disease (see chart below) The Child-Pugh Class C score is obtained by adding the points for all 5 criteria in this table. Any patient having a score of 10 15 falls into Group C (severe hepatic impairment) which would be considered exclusion for this study.

Class A: 5 6 points Class B: 7 9 points Class C: 10 15 points Clinical and Lab Criteria 1 Points assigned 2 3 Total Bilirubin < 2mg/dL or 2 - 3 mg/dL or > 3 mg/dL or SI units < 34 mol/Lmol/L 34 51 mol/Lmol/L > 51 mol/Lmol/L Serum Albumin > 3.5 g/dL or 2.83.5 g/dL < 2.8 g/dL or SI units > 35 g/L 28 35 g/L < 28 g/L Prothrombin time < 4 seconds 4 6 seconds > 6 seconds or INR < 1.7 1.7 2.3 > 2.3 Ascites* Absent Slight Moderate Encephalopathy None Moderate Severe * Refer to ultrasound results. If ascites has been drained in the past, it should be considered Moderate. 5. Pregnant or lactating Urine/blood tests for pregnancy will be done on all females of childbearing age by each site as part of standard ACU practice. 6. Contra-indication for Enteral Nutrition: intestinal occlusion or perforation, abdominal injury. Being NPO is not a contraindication for Enteral Nutrition. 7. Patient with injuries from high voltage electrical contact. NOTE: Thermal injuries from low voltage electrical contact are acceptable for the study. 8. Patients who are moribund: Not expected to survive the next 72 hours. (An isolated DNR does not fulfill this criteria.) 9. Patients with extreme body size: BMI <18 or >50 kg/m2 10. Enrollment in another industry sponsored ACU intervention study Co-enrollment in academic studies will be considered on a case by case basis. 11. Received glutamine supplement for > 24 hours prior to randomization This refers to regular glutamine administration for a period of 24 hours or more prior to randomization. 12. Known allergy to maltodextrin, cornstarch, corn, corn products or glutamine. If the patient meets all inclusion criteria and does NOT meet any of the above exclusion criteria, patient 7 is eligible for randomization and you may proceed to the Pre-randomization/Randomization form. Randomization Number Exclusion Criteria ScreeningExclusion

1. >72 hours from admission to (your) Acute Care Unit to time of consent Yes No 2. Patients younger than 18 years of age Yes No Yes No Yes No 5. Pregnant or lactating (urine/blood tests for pregnancy will be done on all women of childbearing age by each site as part of standard ACU practice). Yes No 6. Contra-indication for EN (intestinal occlusion or perforation, intra-abdominal injury). Yes No Yes No Yes No Yes No Yes No 11. Received glutamine supplement for >24 hours prior to randomization. Yes No 12. Known allergy to maltodextrin, cornstarch, corn, corn products or glutamine. Yes No 3. Renal Dysfunction - In patients without known renal disease, renal dysfunction defined as a serum creatinine >171 mol/Lmol/L or >1.93 mg/dL or a urine output of less than 500 mL/last 24 hours (or 80 mL/last 4 hours if a 24 hour period of observation is not available). - In patients with acute or chronic renal failure (pre-dialysis), an absolute increase of >80 mol/Lmol/L or >0.9 mg/dL from baseline or pre-admission creatinine or a urine output of <500 mL/last 24 hours (or 80 mL/last 4 hours) will be required.

- Patients with chronic renal failure on dialysis will be excluded. 4. Liver cirrhosis: Child-Pugh Class C liver disease. 7. Patients with injuries from high voltage electrical contact. 8. Patient who is moribund (not expected to survive the next 72 hours). 9. Patients with extreme body sizes: BMI < 18 or > 50 kg/m 2 10. Enrollment in another industry sponsored ACU intervention study (coenrollment in academic studies will be considered on a case by case basis). 8 Randomization Number Pre Randomization / Randomization Instructions General Instructions If inclusion criteria are present AND no exclusion criteria are met the patient is considered eligible for randomization into the study. Complete all fields as indicated. Patient Eligibility Confirmed by MD Confirm eligibility of the patient with the site investigator or sub-investigator. Approached for Consent Was the SDM or patient approached for consent? Select Yes or No. If No, select the primary reason the SDM or patient was not approached for consent. If Other is selected, enter text explaining the reason not approached for consent. Reason not approached for consent Consent Obtained Reason consent not obtained Enter the name of the physician who confirmed patient eligibility. This individual should be listed on the Site Delegation of Authority Log. o Next of kin or SDM not available o Missed patient o Language barriers o Family dynamics o Recommendation of the clinical team o CRS unavailable o Pharmacy unavailable o Other, please specify _________________ Was consent obtained from the SDM or patient? Select Yes or No. If No, select the primary reason consent was not obtained. If Other is selected, enter text explaining the reason consent was not obtained. o Too Overwhelmed o Not interested o Did not respond (timed out) o Other, please specify ________________ Consent Date and Time If consent was obtained, record the consent date and time: Enter date in the format yyyy-mm-dd Enter the time using the 24 hr clock in the format hh:mm Height and

Pre-Burn Weight Record the patients height and weight. Record up to two decimal points, eg. 82.67 kg Enter the patients height in either centimetres or inches. Select the unit of measure. Enter the patients pre-burn dry weight in either kilograms or pounds. Select the unit. Indicate how the height and weight were each obtained: o Measured (obtained by a weighing scale) o Estimated (by patient, family or healthcare professional) o Unknown (no documentation to indicate how the value was obtained) Click the Save button at the bottom of the completed Pre-Randomization form to Randomize your patient. Save and Randomize Randomization The Randomization Confirmation page will display the Randomization number; Confirmation randomization date and time; height; weight; BMI; and dosing weight for the patient. 9 Randomization Number Pre Randomization Did you confirm eligibility of the patient with the site investigator, or sub-investigator? o Yes o No o Yes o No Please indicate the name of the physician who confirmed patient eligibility Was SDM/patient approached for consent? If No, please indicate why SDM/patient was not approached for consent (select the primary reason) o Next of kin or SDM not available o Missed patient o Language barriers o Family dynamics o Recommendation of the clinical team o CRS unavailable o Pharmacy unavailable o Other, please specify _________________ If Yes, was consent obtained from the SDM/patient? o Yes If No, choose the most important reason why consent was not obtained (select the primary reason) o No o Too Overwhelmed o Not interested o Did not respond (timed out) o Other, please specify _________________ If Yes, record the following: Consent Date (yyyy-mm-dd) Consent time (hh:mm) (24 hour clock) o Measured Height __________

Weight __________ o cm o kg o inches or o Measured o Estimated o Unknown o lbs or o Estimated o Unknown Randomization Date and time of randomization 2 0 Y Y : Y Y M M D D H H M M (24 hour clock) Pharmacy must be notified as soon as patient is randomized 10 Data Collection REDCap (Electronic Data Capture System) REENERGIZE - Definitive Access REDCap at the following web address: https://ceru.hpcvl.queensu.ca/EDC/redcap/ 11 Randomization Number Baseline Instructions General Instructions Complete all of the information by selecting the appropriate box and entering the required data for each field as indicated. These data are to be collected once, at baseline.

Age Enter the age of the patient in years at the time of screening (patients must be > 18 years of age to be eligible to participate in The RE-ENERGIZE Study). Sex Select the appropriate box (female or male). Ethnic Group Choose the appropriate patient ethnicity from the following list: Asian or Pacific Islander Black or African American East Indian Hispanic Native White or Caucasian Other (please specify) APACHE II score Go to the following website http://www.sfar.org/scores2/apache22.php to calculate the APACHE II score. Record the calculated score. Use variables within the first 24 hrs of this ACU admission. If variables are not available from the first 24 hrs, go outside the 24 hr window and use data closest to ACU admission. NOTE: ensure the units that you are using for serum sodium, potassium and white blood count are correct. Comorbidities Select all comorbidities on the list provided. Only those comorbidities found on the taxonomy listing should be recorded. If no comorbidities are present, select No comorbidities History of Alcohol abuse: If a subject has a documented history of alcohol abuse in the medical chart, it should be recorded in the CRF. If alcohol abuse is not documented in the chart, do not record it as a comorbidity. Tobacco use Indicate whether the patient is a current smoker or uses tobacco, Yes or No. If you are not able to obtain this information, select 'Not Available'. Hospital admit Enter the date and time of hospitalization. This is the time of initial presentation to your emergency department or hospital ward, whichever is the earliest. If the patient is admitted directly to the ACU, this date and time becomes the Hospital admit date and time. If the admit time is not available, enter the time of the first documentation. ACU admit Enter the date and time of ACU admission. If the patient is admitted directly to the ACU, this date and time is the same as the Hospital admit date and time. If the admit time is not available, enter the time of the first chart documentation. Co-enrollment Is the patient co-enrolled in another academic ACU study? If Yes, then enter the name(s) of the study(ies). Date and time of burn Enter the date and time the burn injury occurred. If the time of the burn is not available , select 'No time available'. Type of burn Select the type of burn that best describes the nature of the thermal burn injury from the list below (select only one). Frostbite is NOT considered a type of burn for this study. Scald Do NOT Include Fire (Includes both flame and flash burns) Electrical Burns

Chemical Frost Bite Radiation Steven-Johnson Syndrome (SJS) Unknown Toxic Epidermal Necrolysis (TEN) Other (please specify) ______________ Burn Size expressed as % TBSA Record the total burn size as percent Total Body Surface Area (%TBSA). This assessment is made by the attending surgeon/physician based on her/his clinical judgment and confirmed by the SI/sub-I, if not the same person. Record TBSA in the nearest whole number rounding up from 0.5 and down from 0.4; i.e. 26.5% is recorded as 27% and 26.4% is recorded as 26%. High Dose Vitamin C resuscitation Indicate whether the patient received high dose Vitamin C as part of her/his resuscitation protocol (approximated as 66mg/kg/hr) by selecting Yes or No. 12 Randomization Number Baseline Age (years) Sex Ethnic group years o Female o Male o Asian or Pacific Islander o Black or African American o East Indian o Hispanic o Native o White or Caucasian o Other (Please specify): APACHE II Comorbidities (If Yes, select from the list provided on the next page) Tobacco Use Hospital Admit Date and Time o Yes o No o Yes o No o Not Available (yyyy-mm-dd) (hh:mm) (24 hour clock) (yyyy-mm-dd) (hh:mm) (24 hour clock) ACU Admit Date and Time

Is this patient co-enrolled in another academic ACU study? If Yes, Please specify: o Yes o No Burn Injury Date and Time (yyyy-mm-dd) Type of Burn (Select only one) o Scald o Fire (includes flame and flash) o Chemical o Radiation Burn Size expressed as % Total Body Surface Area (TBSA) Did the patient receive high dose Vitamin C (hh:mm) (24 hour clock) o No Time Available o Unknown o Other (Please specify): %TBSA o Yes o No as part of her/his resuscitation protocol (approximately 66mg/kg/hr)? 13 Randomization Number Comorbidities Check all the comorbidities that apply. If the patient has no comorbidities, check 'No Comorbidities'. No Cormorbidities Myocardial 1. Angina 2. Arrhythmia 3. Valvular 4. Myocardial infarction 5. Congestive heart failure (or heart disease) Vascular 6. Hypertension 7. Peripheral vascular disease or claudication 8. Cerebrovascular disease (Stroke orTIA) Pulmonary 9. Chronic obstructive pulmonary disease (COPD, emphysema) 10. Asthma Neurologic 11. Dementia 12. Hemiplegia (paraplegia) 13. Neurologic illnesses (such as Multiple sclerosis or Parkinson's) Endocrine 14. Diabetes Type I or II 15. Diabetes with end organ damage 16. Obesity and/or BMI > 30 (weight in kg/(ht in meters)2 Renal 17. Moderate or severe renal disease Gastrointestinal

18. Mild liver disease 19. Moderate or severe liver disease 20. GI Bleeding 21. Inflammatory bowel 22. Peptic ulcer disease 23. Gastrointestinal Disease (hernia, reflux) Cancer/immune 24. Any Tumor 25. Lymphoma 26. Leukemia 27. AIDS 28. Metastatic solid tumor Psychological 29. Anxiety or Panic Disorders 30. Depression Muskoskeletal 31. Arthritis (Rheumatoid or Osteoarthritis) 32. Degenerative Disc disease (back disease, spinal stenosis or severe chronic back pain) 33. Osteoporosis 34. Connective Tissue disease Miscellaneous 35. Visual Impairment (cataracts, glaucoma, macular degeneration 36. Hearing Impairment (very hard of hearing even with hearing aids) 37. Alcohol Abuse 14 Randomization Number Organ Dysfunction Instructions General Instructions These data are collected once at baseline for calculation of modified SOFA score. All data should be collected within the first 24 hours after admission. If data is not available within the first 24 hours, go outside the 24 hour period and record data closest to admission. Lowest PaO2/FiO2 (PF ratio) Record the lowest PaO2/FiO2 (PF ratio) observed on the study day by selecting from the options below. The PaO2 and FiO2 values should come from the same blood gas measurement. If no PF ratio record N/A by selecting the first option. Lowest Platelets Record the lowest serum platelets observed on the study day by selecting from the options below. If no Platelet data record N/A by selecting the first option. Vasopressors > 400 mmHg or N/A 300 399 mmHg 200 299 mmHg 100 199 mmHg with respiratory support < 100 mmHg with respiratory support > 150 x 109/L (103/L) or N/A

100 - 149 x109/L (103/L) 50 - 99 x109/L (103/L) 20 - 49 x109/L (103/L) < 20 x109/L (103/L) Not Available Indicate whether the patient received vasopressors or not be selecting Yes or No. If Yes, select the highest dose received from the 3 groupings below: Dopamine 5 g/kg/min or Dobutamine (any dose) Dopamine 6 - 15 g/kg/min or Epinephrine 0.1 g/kg/min or Norepinephrine 0.1 g/kg/min Dopamine > 15 g/kg/min or Epinephrine > 0.1 g/kg/min or Norepinephrine > 0.1 g/kg/min If No, enter MAP (mean-arterial pressure), see below. MAP (mean arterial pressure) Indicate the lowest MAP observed during the study day by selecting from the options below : < 70 mmHg > 70 mmHg If the MAP is not available you can calculate it using the formula: MAP = 1/3 lowest systolic BP + 2/3 corresponding diastolic BP Or use the tool on the website: http://www.mdcalc.com/mean-arterial-pressure-map/ Urine output (mL) Indicate the volume range of urine output for the study day by selecting from the list below: < 200 mL/day 200 - 499 mL/day >= 500 mL/day Not Available 15 Randomization Number Organ Dysfunction (Baseline) Date (yyyy-mm-dd) Lowest PaO2/FiO2 (PF ratio) Lowest Platelets Vasopressors Did the patient receive vasopressors? If Yes, select the highest dose received during the study day. > 400 mmHg or N/A 300 399 mmHg 200 299 mmHg 100 199 mmHg with respiratory support < 100 mmHg with respiratory support > 150 x 109/L (103/L) or N/A 100 - 149 x109/L (103/L) 50 - 99 x109/L (103/L) 20 - 49 x109/L (103/L) < 20 x109/L (103/L) Yes No Dopamine 5 g/kg/min or

Dobutamine (any dose) Dopamine 6 - 15 g/kg/min or Epinephrine 0.1 g/kg/min or Norepinephrine 0.1 g/kg/min If No, enter MAP below. MAP (lowest) Urine output Dopamine > 15 g/kg/min or Epinephrine > 0.1 g/kg/min or Norepinephrine > 0.1 g/kg/min < 70 mmHg > 70 mmHg < 200 mL/day 200 - 499 mL/day > 500 mL/day Not Available 16 Randomization Number Invasive Mechanical Ventilation / Renal Replacement Therapy (Dialysis) Instructions General Instructions These data are collected to determine the duration of invasive mechanical ventilation and need for renal replacement therapy (dialysis). Duration of Data Collection Invasive Mechanical Ventilation #1 Start These data are to be collected at start and stop of invasive mechanical ventilation and renal replacement therapy (dialysis). Indicate whether the patient received invasive mechanical ventilation during this ACU stay by selecting Yes or No. If Yes, enter the actual start date and time of invasive mechanical ventilation, even if this occurs at an external institution or in the field before admission to your unit. This may not be the same time that the patient was intubated, but should be the time invasive mechanical ventilation was started. If the start time is not available, enter the start date and check the Not available option for time. Do not record episodes of temporary ventilation (defined as <48 hrs i.e. needed for operating procedures, etc). Stop After the patient has been successfully breathing without mechanical ventilation for > 48 hours, record the stop date and time mechanical ventilation was discontinued. Patients will be considered breathing without mechanical ventilation in any of these instances: extubated and on face mask (nasal prong) intubated or breathing through a t-tube tracheostomy mask breathing. continuous positive airway pressure (CPAP) <=5cmH2O without pressure support or intermittent mandatory ventilation assistance. If patient is transferred out of the ACU to another institution and is still receiving mechanical ventilation, record the transfer date and time as the mechanical ventilation discontinuation date and time. If the patient expired while mechanically ventilated, select 'Same as death date & time'. Was Mechanical Ventilation Re-instituted? Mechanical Ventilation

Episodes #2 - #5 Renal Replacement Therapy (Dialysis) Was first RRT start due to Acute Renal Failure? RRT (Dialysis) Start RRT (Dialysis) Stop If the patient is still mechanically ventilated 3 months after ACU admission, select 'Still vented 3 months post ACU admission'. Answer Yes or No to the question Was mechanical ventilation re-instituted > 48 hours from the last mechanical ventilation stop date/time?. If No, proceed to the RRT (Dialysis) section. If the mechanical ventilation was re-instituted > 48 hours after the first episode was discontinued, select Yes to open the data entry fields to record another episode of mechanical ventilation. Record up to 5 episodes of mechanical ventilation by answering Yes at the end of each previous event recorded. Follow the instructions for recording start and stop dates of Mechanical Ventilation episodes as outlined in #1 above. Exception: Start Time must be recorded for episodes #2 - #5, there is not a Not Available option. Do not record episodes of temporary ventilation (defined as <48 hrs i.e. needed for operating procedures, etc). Indicate whether the patient received RRT during this ACU stay by selecting Yes or No. If Yes, respond to the question The first time renal replacement therapy (dialysis) was started, was it due to acute renal failure? by selecting Yes or No. If Yes, record the date RRT (dialysis) started Select one of the following related to discontinuation of RRT: Same as death date & time At 3 months, still on renal replacement therapy (dialysis) in hospital Continued past hospital discharge Actual stop date (Record the date dialysis was permanently discontinued. This may occur on the ward.) 17 Invasive Mechanical Ventilation Randomization Number Date (yyyy-mm-dd) Mechanical Ventilation # 1 Did the patient ever receive invasive mechanical ventilation? Mechanical ventilation stop: Time (24 hour clock) o Yes (Record start date & time) If start time is not available o Not available o No o Record stop date & time o Same as death date & time o Still vented 3 months post ACU admission Mechanical Ventilation # 2 Was mechanical ventilation re-instituted 48 hours from the last ventilation discontinuation date/time? Mechanical ventilation stop: o Yes (Record start date & time) o No o Record stop date & time o Same as death date & time

o Still vented 3 months post ACU admission Mechanical Ventilation # 3, #4, #5 Was mechanical ventilation o Yes (Record start date & time) re-instituted 48 hours from o No the last ventilation discontinuation date/time? Mechanical ventilation stop: o Record stop date & time o Same as death date & time o Still 3 months post ACU admission Renal Replacement Therapy (Dialysis) Did the patient receive renal replacement therapy (dialysis) during this ACU stay? The first time renal replacement therapy (dialysis) was started, was it due to acute renal failure? o Yes o No o Yes (Continue to the next row) o No (Do not complete below) -Start Date Date -Stop Date Same as death date & time At 3 months, still on renal replacement therapy (dialysis) in hospital Continued past hospital discharge Actual stop date Date 18 Randomization Number Study Intervention General Instructions Duration of Data Collection Study Intervention Start Date and Time Study Intervention started more than 2 hours from Randomization Study Intervention Stop Date and Time Study Intervention Prescription Study Intervention Prescription Changes Study intervention is to be started within 2 hours of randomization. These data are to be collected when study supplements are first started and when study supplements are finally stopped. In addition, any prescription changes will be recorded on this form. Enter the date and time study supplements were first started in the format yyyymm-dd and hh:mm If the study intervention is started more than 2 hours after randomization, select Yes and choose the reason from the list provided:

Pharmacy delay Patient NPO for surgery Awaiting tube placement and/or verification Patient not available (procedure) Nurse not available Other (specify): _______________________ If you select Other, you must provide and explanation in the space provided. Enter the date and time study supplements were finally stopped in the format yyyy-mm-dd and hh:mm The stop date should be at the end of the study period, i.e. > 7 days after the last successful grafting operation or at discharge from ACU or 3 months from ACU admission, whichever occurs first. Select the initial study intervention prescription in grams per day from the dropdown list: 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100 Each packet contains 5 grams of study intervention. If 10 packets per day are prescribed, select 50 from the prescription dropdown box. If the study intervention prescription changes, select Yes to the question Did the study intervention prescription change? to open the data entry fields to record the new prescription. Enter the Date and Time the prescription change occurred. Enter the dosing weight associated with the new prescription. Select the new prescription in grams per day. Record up to 6 prescriptions by selecting Yes to the question Did the study intervention prescription change? after each prescription entry. NOTE: Study Intervention prescription should not change. EXCEPTION: If the patient has a change in body weight sufficient for the clinical team to alter dosage of clinical treatments, the study treatment should also be adjusted. This decision is made by the Site Investigator. 19 Randomization Number Study Intervention Date and Time first dose of study intervention administered Was Study Intervention started > 2 hours from Randomization? If Yes, indicate the reason: (yyyy-mm-dd) o Yes (hh:mm) (24 hour clock) o No o Pharmacy delay o Patient NPO for surgery o Awaiting tube placement and/or verification Patient not available (procedure) Nurse not available Other (specify): ______________________________ Date and Time the last dose of study intervention administered Initial Study Intervention Prescription (yyyy-mm-dd) (hh:mm) (24 hour clock)

grams/day Did the study intervention prescription change? If Yes, record: Date and Time of the change o Yes (yyyy-mm-dd) Dosing weight for this prescription (kg) Prescription in grams per day (hh:mm) (24 hour clock) kg 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100 grams/day Did the study intervention prescription change? If Yes, record: Date and Time of the change o Yes (yyyy-mm-dd) Dosing weight for this prescription (kg) Prescription in grams per day (hh:mm) (24 hour clock) kg 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100 grams/day Did the study intervention prescription change? If Yes, record: Date and Time of the change o Yes (yyyy-mm-dd) Dosing weight for this prescription (kg) Prescription in grams per day (hh:mm) (24 hour clock) kg 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100 grams/day 20 Randomization Number Daily Monitoring General Information These data are collected to determine the compliance to the prescribed dose of the study intervention and to identify any dose related Protocol Violations. Study intervention is to be started within 2 hours of randomization. Duration of Data Collection (recommended) Prescribed # grams per day

Date # Times IP administered # Grams given Route Total grams received today Percentage of study intervention received Dose Related Protocol Violation Protocol Violation (IP dosing <80% over a 3 day average) Given the material affect on the study, these data are to be collected daily as close to REAL TIME as possible and as follows: Study Intervention: from randomization to > 7 days post last successful grafting operation, or until ACU discharge, or until 3 months from ACU admission, whichever comes first. Dose related Protocol Violations: for duration of study intervention administration. To assist in determining the daily percentage of IP received, record at the top of each daily monitoring worksheet the number of grams per day of investigational product (IP) the patient is to receive. NOTE: This data is not entered on the Daily Monitoring forms in REDCap. Enter the date for which the data is being collected. Enter the data in REDCap on the date corresponding to the date you entered on the worksheet. Select the number of times, from 0 to 10, the study intervention was given on this study day. The same number of entry fields will appear on the form in REDCap for that day. Select the # grams given, from 5 to 30, at each interval as documented in the medical chart. Each packet of IP contains 5 grams. If dose is recorded in the medical chart as # of packets administered, multiply # of packets by 5 and select the # of grams administered. Select the route by which the study intervention was administered at each interval, EN or PO. To assist in calculating the percentage received, add the number of grams given at each interval and record the total given each day. NOTE: This data is not entered in REDCap. Divide the total number of grams actually given by the number of grams prescribed per day (you should record the prescribed g/day on the top of the daily monitoring worksheet) to determine the percentage of study intervention received. Record the percentage in the space provided. Indicate if there is a dose related protocol violation for the day by selecting Yes or No. A protocol violation with the delivery of the study intervention occurs when the patient receives < 80% of the prescribed daily dosage over a 3 day average. Report a dose related protocol violation when both of the following are true: Dose received on the indicated day is < 80% prescribed Dose received over a 3 day average is < 80% prescribed Example: Prescribed Dose: 80% Prescribed: 35g/day 28g Dose received Day 6: 30g Day 7: 20g Day 8: 30g Total dose received over 3 days = 80g 3 day average dose is 80 g/ 3 = 26.67g Report Day 7: Dose received is < 80% AND 3 day average is < 80 % Do Not report Day 6 or Day 8: 3 day average is <80% BUT Dose received is NOT <80% If < 80% is received over a 3 day average, complete the Protocol Violation Form in REDCap within 24 hours of becoming aware. Refer to the Protocol Violations section in these worksheets for detailed instructions. 21 Randomization Number

Daily Monitoring Prescribed # _______ gm/day Date: yyyy-mm-dd # times IP given today (circle one) 1) # grams given (circle one) Route 2) # grams given (circle one) Route 3) # grams given (circle one) Route 4) # grams given (circle one) Route 5) # grams given (circle) Route 6) # grams given (circle one) Route 7) # grams given (circle one) Route 8) # grams given (circle one) Route 9) # grams given (circle one) Route 10) # grams given (circle one) Route TOTAL # grams given today Percentage of prescribed given Protocol Violation 0 1 6 7 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN

5 20 o EN % o Yes o No 2 3 4 5 8 9 10 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO Page #:_____ 0 1 6 7 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN

5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN % o Yes o No 2 3 4 5 8 9 10 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 0 1 6 7 5 20 o EN 5 20 o EN 5 20 o EN 5

20 o EN 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN 2 3 4 5 8 9 10 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 0 1 6 7 5 20 o EN 5 20 o EN

5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN % o Yes o No 2 3 4 5 8 9 10 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO

0 1 6 7 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN 5 20 o EN 2 3 4 5 8 9 10 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10 15 25 30 o PO 10

15 25 30 o PO % o Yes o No % o Yes o No 22 Randomization Number Laboratory Instructions Duration of Data Collection These data are to be collected as follows: Daily for 2 weeks: From admission to the ACU through study day 14 Weekly: From day 15 to > 10 days post last successful graft (stop of study intervention plus 3 days), discharge from the ACU, or 3 mos. after admission, whichever comes first. o Collect weekly lab data from a single day during that study week defined as +/- 24 hours from study day 21, 28, 35, 42, 49, 56, 63, 70, 77, 84 and 90. o If there is no value available on the specified date, record the value from an adjacent day. If there is no value available for that study week, record N/A. Date Enter the dates corresponding to the calendar day. Enter the data on the corresponding date in REDCap. Creatinine, serum Record the highest serum creatinine observed on the study day. (highest) T-bilirubin (highest) Record the highest serum total bilirubin observed on the study day. Urea (highest) Record the highest serum urea observed on the study day. Glucose closest to 08:00 Record the glucose closest to 8:00 AM, 6 hrs (i.e. from 02:00 to 14:00 hrs), observed on the study day. Value may be from a blood draw or from a bedside glucometer. For each requested result above, if there is no value available to record, select 'Not Available'. 23 Randomization Number Laboratory Page #:_____ Date (yyyy-mm-dd) Creatinine, serum (highest) o Not available o Not available o Not available

o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available o Not available

o Not available T-bilirubin (highest) Urea (highest) Glucose closest to 08:00 A.M. Date (yyyy-mm-dd) Creatinine, serum (highest) T-bilirubin (highest) Urea (highest) Glucose closest to 08:00 A.M. 24 Randomization Number Nutrition Assessment/Timing Instructions General Instructions Duration of Data Collection Baseline Assessment These data are collected to determine how well the patient is being fed, i.e. the nutritional adequacy (% calories and protein received/prescribed) and the timing of initiation of nutrition. Work with your dietitian, or person responsible for assessing and monitoring the nutritional needs of patients, to obtain this information. These data need to be calculated at baseline (ACU admission or at the first dietitian assessment) through study Day 12. Use the patients pre-burn dry weight or usual weight when calculating energy and protein needs. For Obese patients, if your standard practice is to adjust for obesity, follow your standard practice. If you do not have an obesity adjustment practice, use the formula below: Adjusted Body Weight (ABW) = Ideal Body Weight (IBW) based on a BMI of 25 + [(pre-burn dry weight IBW) x 0.25] Prescribed energy needs are to be calculated by using Indirect Calorimetry, a predictive equation, or a simple weight-based formula but on average, should not lead to a prescription of less than 30 kcal/kg. Prescribed Protein needs are to be calculated by using the following: If > 50% burns, use 1.5g/kg/day to 2.5g/kg/day If < 50% burns, use 1.2 g/kg/day to 2 gm/kg/day Note: Energy and protein requirements are independent of the formula prescribed. Do NOT change prescription to accommodate a formula change. Prescription Date Enter the date of the prescription in the format yyyy-mm-dd. Prescribed Energy Enter the prescribed daily energy needs in calories (kcal). and Protein needs Enter the prescribed daily protein needs in grams. Changes in Indicate if the prescription changed by selecting Yes or No to the question, Was another Prescription prescription made? If Yes the data entry fields will open to enter the new prescription information. Enter the prescription date and prescribed energy and protein needs. Repeat the steps above to enter up to 6 prescriptions. Do Not record changes in prescription after study day 12. Enteral Nutrition Indicate if enteral nutrition was given by selecting Yes or No to the question, Was EN Received received during this ACU admission?. EN Start If EN was received during the first 12 Days after ACU admission, enter the date and time EN

was started. If EN started after Day 12, select EN not initiated during first 12 days in ACU EN Stop Select one of the following related to permanent discontinuation of EN: Same as death date & time Still receiving EN > 12 days post ACU admission Actual EN stop date & time (If EN stopped < 12 days after ACU admission.) Parenteral Nutrition Indicate if parenteral nutrition was given by selecting Yes or No to the question, Was PN Received received during this ACU admission?. PN Start PN Stop If PN was received, enter the date and time PN was started. Select one of the following related to permanent discontinuation of PN: Same as death date & time Still receiving PN 3 months post ACU admission Actual PN stop date & time (If d/c on PN, record ACU d/c as stop date & time.) 25 Randomization Number Nutrition Assessment Baseline Date prescription made (yyyy-mm-dd) Prescribed Energy Needs kcal Prescribed Protein Needs grams Was another prescription made? o Yes o No Only record prescription changes for this patient made from ACU admission to Study Day 12. Note: Energy and protein requirements are independent of the formula prescribed. Do NOT change prescription to accommodate a formula change. Assessment #2 Date prescription made (yyyy-mm-dd) Prescribed Energy Needs kcal Prescribed Protein Needs grams Was another prescription made? o Yes o No Assessment #3 Date prescription made (yyyy-mm-dd) Prescribed Energy Needs kcal Prescribed Protein Needs grams Was another prescription made? o Yes o No Was Enteral Nutrition (EN) received during this ACU admission? If Yes, record EN Start date and time: EN Stop date and time: If Actual EN Stop date & time selected or if patient discharged from ACU on EN Enter date & time: Was Parenteral Nutrition (PN) received during this ACU admission? If Yes, record PN Start date and time: PN Stop date and time: If Actual PN Stop date & time selected or if patient discharged from ACU on PN Enter date & time: Yes, started during first 12 days of ACU admission Yes, started after first 12 days of ACU admission

No (hh:mm) (yyyy-mm-dd) (24 hour clock) Select one: Same as death date & time Still receiving EN 12 days post ACU admission Actual EN stop date & time (hh:mm) (yyyy-mm-dd) (24 hour clock) Yes, started during first 12 days of ACU admission Yes, started after first 12 days of ACU admission No (hh:mm) (yyyy-mm-dd) (24 hour clock) Select one: Same as death date & time Still receiving PN 12 days post ACU admission Actual PN stop date & time (hh:mm) (yyyy-mm-dd) (24 hour clock) 26 Daily Nutrition Instructions Randomization Number General Instructions These data are collected to determine the adequacy of all types of nutrition (calories and protein) received. Duration of Data Collection Date Enteral Nutrition Today? (If No) These data are to be collected daily from Study Day 1 (ACU admission) until Study Day 12, or ACU discharge or 3 months after ACU admission, whichever comes first. Enter the dates corresponding to the calendar day. For each day, indicate whether the patient received enteral nutrition (EN), Yes or No. If No to Enteral Nutrition, using the list below, indicate ALL the reason(s) the patient did not receive EN on the specified Study day by placing the number(s) in the box(es) provided: NPO for endotracheal extubation or intubation or other bedside procedure. If 'Other' is indicated, please also check the 'Other' box and specify the reason. NPO for operating procedure NPO for radiology procedure High NG drainage Increased abdominal girth, abdominal distension or pt. discomfort Vomiting or emesis Diarrhea No enteral access available / enteral access lost, displaced or malfunctioning Inotropes, vasopressor requirement Patient deemed too sick for enteral feeding On oral feeds Reason not known Other , please specify___________________ Enteral Nutrition Today? (If Yes) Formula Total kcals Total Protein Protein Supplements

Total Kcals Total Protein If Yes to EN, record the enteral formula received. You may record up to 3 different formulas used each day. Record the first formula received in the spaces provided for 'Formula 1' and so on. In the event that the patient receives more than 3 formulas in one day, select the 3 formulas that provide the largest volumes. When entering in REDCap, select the company from the dropdown list, then the formula. If the company is not listed, select Miscellaneous and enter the company name. If the formula is not listed, select Other (specify) and enter the formula name in the space provided. To open the form to enter another formula, select Yes to the question Was a second EN formula given? Repeat steps above to enter a third EN formula. Record the total calories (kilocalories) and protein from all the EN formulas received in the study day. Do not record the calories from propofol (volume to be entered separately). Do not include protein supplements as part of this total (collected separately). Record whether a protein supplement was received, 'Yes' or 'No'. You may record 2 different protein supplements each day. If a protein supplement was received, select the product given from the dropdown list in REDCap. If the supplement is not listed, select Other and enter the company and product name in the space provided. To open the form and enter another protein supplement, select Yes to the question Add another protein supplement? If more than two protein supplements given, record the 2 that provide the most amount of protein. Record the total calories and protein received from protein supplements. Do Not use formulas that are listed with (restricted) beside the name in REDCap. Parenteral Nutrition For each day, indicate whether the patient received parenteral nutrition, Yes or No. Total Kcals Total Protein Oral feeding Propofol If Yes, record the total calories and grams of protein received from parenteral nutrition. Do not record the calories from propofol (volume to be entered separately). Record if the patient received any oral nutrition, Yes or No. Record oral nutrition regardless of EN or PN given. Record if the patient received a continuous infusion of Propofol for 6hrs, Yes or No. Record propofol received each day, regardless of EN, PN or neither received. Total mL Insulin Total units Opiates Motility agents If propofol received, record the total volume in mL received the 24 hour period. Record if insulin was received, 'Yes or 'No. If the information is not documented, select 'Not Available'. If insulin was given, record the total units received in the 24 hour period from all insulin: IV, subcutaneous and bolus. Record if any opiates were received, 'Yes' or 'No'. If the information is not documented, select 'Not Available'. Record if any motility agents were received, 'Yes' or 'No. If the information is not documented, select 'Not Available'. Common motility agents include, but are not limited to: metoclopramide; erythromycin; domperidone Do NOT record stool softeners as motility agents. 27 Daily Nutrition Randomization Number Page #:_____ (Collect from Study Day 1 through Study Day 12 only) Date (yyyy-mm-dd) Enteral Nutrition (EN) given? If EN NOT received (Select all that apply) o Yes NPO for endotracheal extubation or intubation or other bedside procedure NPO for operating procedure NPO for radiology procedure

High NG drainage Increased abdominal girth, abdominal distension or pt. discomfort Vomiting or emesis Diarrhea No enteral access available / enteral access lost, displaced or malfunctioning Inotropes, vasopressor requirement Patient deemed too sick for enteral feeding On oral feeds Reason not known o No o Yes o No o Yes o No o Yes o No o o o o o o o o o o o o o o o o o o o o o o o o o o o o o o o o o o

o o o o o o o o o o o o o o Other (Please specify) If EN received (complete below) Do NOT use formulas with (restricted) beside the name in REDCap Formula 1 (company and formula name) Formula 2 (company and formula name) Formula 3 (company and formula name) Total Kilocalories from EN Total Protein from EN Protein Supplement given? o Yes o No o Yes o No o Yes o No o Yes o No o Yes o No o Yes o No o Yes o No o Yes o No o Yes o No o Yes o No

o Yes o No o Yes o No o Yes o No o Yes o No o Yes o No o Yes o No o Yes o No o Yes o No o Yes o No o Yes o No o Yes o Yes o No o No o Yes o Yes o No o No o Yes o Yes o No o No o Yes o Yes o No o No Protein Supplement Name(s) Total Calories from Protein Supplement Total Protein from Protein Supplement Parenteral Nutrition (PN) given? Total Calories from PN Total Protein from PN

Oral Nutrition given? Medications Propofol received for 6 hours? Volume of propofol received (mL) Insulin received? Insulin total dose in units Opiates received? Motility Agents (metoclopramide, erythromycin, domperidone, other) received? 28 Enrollment Number ENTERAL NUTRITION FORMULAS There are over 400 EN Formulas listed in REDCap. Select the company, choose Miscellaneous if company is not listed. Select the formula from the dropdown list. If it is not listed, select Other (specify) and enter the formula name in the space provided. 29 Randomization Number Burn Related Operative Procedures Instructions General Instructions Duration of Data Collection Date Burn related operative procedure today? Was the Operative procedure planned or unplanned? Type of Operative Procedure These data are collected to determine the frequency and type of burn related operative procedures that the patient undergoes during the study. Note: These data only need to be completed on study days that a burn related operative procedure is performed. Record all burn related operative procedures from Study Day 1 (ACU admit) to > 10 days post last successful grafting (stop of study IP + 3 days) or ACU discharge or 3 months from ACU admission, whichever comes first. Enter the date corresponding to the calendar day that the operative procedure was performed. Select Yes to open the form and record the details of the burn related operative procedure performed on that study day. Indicate if the patient had a planned or unplanned operative procedure by selecting the appropriate box. Select the type(s) of operative procedure(s) performed on the date indicated from the taxonomy provided. If a procedure was performed that is not in the taxonomy, select Other specify and enter the procedure name in the space provided. Select all procedures performed: Surgical excision (tangential or fascial) Excision and temporary covering (xenograft, allograft and artificial skin) Excision and autograft

Delayed autograft Excision and primary closure/composite tissue transfer Other specify (example amputation) _________________________ 30 Randomization Number Burn Related Operative Procedures Page #:_____ Date (yyyy-mm-dd) Burn related operative procedure today? Was the Operative procedure planned or unplanned? o Yes o Yes o Yes o Yes o Yes o Planned o Unplanned o Planned o Unplanned o Planned o Unplanned o Planned o Unplanned o Planned o Unplanned Type of Operative Procedure (Select all that apply) Surgical excision (tangential or fascial) Extension and temporary covering (xenograft, allograft and artificial skin) Excision and autograft Delayed autograft Excision and primary closure/composite tissue transfer Other specify o o o o o o o o o

o o o o o o o o o o o o o o o o Date (yyyy-mm-dd) Burn related operative procedure today? Was the Operative procedure planned or unplanned? Type of Operative Procedure (Select all that apply) Surgical excision (tangential or fascial) Extension and temporary covering (xenograft, allograft and artificial skin) Excision and autograft Delayed autograft Excision and primary closure/composite tissue transfer Other specify o Yes o Yes o Yes o Yes o Yes o Planned o Unplanned o Planned o Unplanned o Planned o Unplanned o Planned o Unplanned o Planned o Unplanned o o o o

o o o o o o o o o o o o o o o o o o o o o 31 Randomization Number Concomitant Medications Instructions General Instructions These data are collected to capture relevant medications that the patient received that may have a material effect on the measured outcomes of the study. Note: administration of propofol; insulin; opiates, and motility agents is recorded on the Daily Nutrition form. Duration of Data Collection Record all concomitant medications started from ACU admission until > 10 Days after the last grafting operation (stop of study IP + 3 days) or discharge from the ACU or 3 months after admission to the ACU, whichever comes first. Date Enter the date corresponding to the calendar day. Heart Rate Record both the highest and the lowest heart rate documented for the patient each study day. Highest Lowest If there is only one heart rate documented, record the documented heart rate as both the highest and the lowest for that day. Were Concomitant Medications received today? Indicate if concomitant medications were received, Yes or No. If the information is not documented, select Not Available.

Select Yes to open the form and record the concomitant medications received. Oxandrolone, Nandrolone and Testosterone Indicate if Oxandrolone, Nandrolone, or Testosterone was received by selecting the appropriate Yes response: Yes, Oxandrolone Yes, Nandrolone Yes, Testosterone No Not Available If none of the 3 were received, select No. If the information is not documented, select Not Available. Beta-Blockers Indicate if any Beta-Blockers were received, 'Yes' or 'No'. If the information is not documented, select Not Available. 32 Concomitant Medications Randomization Number Page #:_____ Date (yyyy-mm-dd) Heart Rate Highest Heart Rate Lowest Heart Rate Concomitant Medications Were Concomitant Medications received today? o Yes o No o Not Available o Yes o No o Not Available o Yes o No o Not Available Was Oxandrolone, Nandrolone or Testosterone received today? o Yes, Oxandrolone o Yes, Nandrolone o Yes, Testosterone o No o Not available o Yes, Oxandrolone o Yes, Nandrolone o Yes, Testosterone

o No o Not available o Yes, Oxandrolone o Yes, Nandrolone o Yes, Testosterone o No o Not available Were BetaBlockers received today? o Yes o No o Not Available o Yes o No o Not Available o Yes, Oxandrolone o Yes, Oxandrolone o Yes, Nandrolone o Yes, Nandrolone o Yes, Testosterone o Yes, Testosterone o No o No o Not available o Not available o Yes o Yes o No o No o Not Available o Not Available Were Concomitant Medications received today? o Yes o No o Not Available o Yes o No o Not Available o Yes o No o Not Available o Yes o No o Not Available Was Oxandrolone, Nandrolone or Testosterone received today? o Yes, Oxandrolone o Yes, Nandrolone o Yes, Testosterone o No o Not available o Yes, Oxandrolone o Yes, Nandrolone o Yes, Testosterone o No o Not available Were BetaBlockers received

today? o Yes o No o Not Available o Yes o No o Not Available o Yes, Oxandrolone o Yes, Oxandrolone o Yes, Nandrolone o Yes, Nandrolone o Yes, Testosterone o Yes, Testosterone o No o No o Not available o Not available o Yes o Yes o No o No o Not Available o Not Available o Yes o No o Not Available o Yes o No o Not Available o Yes o No o Not Available Date (yyyy-mm-dd) Heart Rate Highest Heart Rate Lowest Heart Rate Concomitant Medications o Yes o No o Not Available o Yes, Oxandrolone o Yes, Nandrolone o Yes, Testosterone o No o Not available o Yes o No o Not Available 33 Randomization Number Microbiology Instructions General Instructions & Duration of Data Collection These data are collected to assist in determining the incidence of ACU acquired infections. Record Gram negative bacteremias only. Only record venous or arterial blood cultures that test positive for Gram

negative bacteria that occurred >72 hours after ACU admission until > 10 days post last successful grafting (stop of study IP + 3 days) or ACU discharge or 3 months after ACU admission, whichever comes first. Do not include blood from a catheter line tip. Date sample collected Record the date the sample was collected (i.e. not when the results were reported) in the date format of yyyy-mm-dd. Time sample collected Record the time the sample was collected (i.e. not the time the results were reported) in the format of hh:mm. Gram Negative Culture Species Select all Gram negative bacteremias reported each study day, refer to the table below. Do Not record Gram Positive bacteria reported, see table below: Gram Negative Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Was there another Gram negative culture today? Acinetobacter sp. Aeromonas sp. Alcaligenes sp. Bacteroides sp. Bartonella sp. Bortetella sp. Burkholderia sp. Campylobacter sp. Capnocytophaga sp Chlamydia sp. Citrobacter sp. Coxiella sp. Ehrlichia sp. Eikenella sp. Enterobacter sp. Escherichia sp. Francisella sp. Fusobacterium sp. Hafnia sp. Helicobacter sp.

Haemophilus sp. Klebsiella sp. 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 Legionella sp. Moraxella sp. Morganella sp. Mycoplasma sp. Neisseria sp. Pasteurella sp. Porphyromonas sp. Prevotella sp. Proteus sp. Providencia sp. Pseudomonas sp. Ralstonia sp. Rickettsia sp. Salmonella sp. Salmonella sp. Serratia sp. Shigella sp. Stenotrophomonas sp Streptobacillus sp. Vibrio sp Yersinia sp. Other, please specify Gram Positive Bacteria (Do NOT include) Actinomyces sp. Aerococcus sp. Bacillus sp. Clostridium sp. Corynobacterium sp. Diphteroids sp. Enterococcus sp. Erysipelothrix sp. Lactobacillus sp. Listeria sp. Nocardia sp. Peptostreptococcus/ Peptococcus sp. Propionibacterium sp. Rhodococcus sp. Staphylococcus sp. Streptococcus sp. Record up to 5 different Gram negative bacteremias each day. Select Yes to the question Was there another Gram negative culture today? to open the form and record additional bacteria. Record all different Gram negative bacteria reported. Do

not record the same bacteria more than once on each study day, even if reported from specimens collected at different times on that day. 34 Randomization Number Microbiology ONLY record venous or arterial blood cultures that test positive for Gram negative bacterimia. Date (yyyy-mm-dd) 1) Time (hh:mm) -Gram Negative Culture Number(s) 2) Time (hh:mm) -Gram Negative Culture Number(s) 3) Time (hh:mm) -Gram Negative Culture Number(s) 4) Time (hh:mm) -Gram Negative Culture Number(s) 5) Time (hh:mm) -Gram Negative Culture Number(s) Date (yyyy-mm-dd) 1) Time (hh:mm) -Gram Negative Culture Number(s) 2) Time (hh:mm) -Gram Negative Culture Number(s) 3) Time (hh:mm) -Gram Negative Culture Number(s) 4) Time (hh:mm) -Gram Negative Culture Number(s) 5) Time (hh:mm) -Gram Negative Culture Number(s) 35 Randomization Number Protocol Violation Instructions Protocol Violation Definition General Instructions Duration of Data Collection (when to report) Are you reporting a protocol violation today? Date Violation Occurred Date Violation Discovered Local Investigator Aware? Violation Supporting documentation Action taken by RC

Another Protocol Violation to add? A Protocol Violation is defined as non-compliance with the study protocol and/or procedures that may impact study participant safety, the integrity of study data and/or study participant willingness to participate in the study. For THE RE-ENERGIZE Study, a Protocol Violation occurs when any of the following have occurred: 1) Investigational Product (IP) Daily dose delivered is < 80% prescribed over 3 day average. 2) IP dispensing/dosing error 3) Accidental unblinding of IP 4) Enrollment of a patient that does not fulfill inclusion/exclusion criteria 5) Open label glutamine given 5) Unapproved EN formula given 6) Other, please specify in the space provided. Complete Protocol Violation (PV) forms in REDCap within 24 hours of becoming aware of the violation. Only complete the PV form on days you are reporting a protocol violation. Protocol violations are to be reported from randomization until >10 days post last successful graft (stop of study IP + 3 days) or ACU discharge or 3 months after ACU admission, whichever comes first). Protocol Violations that relate to the <80% dosing delivered do NOT have to be reported on the following days: Day of randomization Day of discharge or end of study treatment (> 7 days post last successful graft) Day of death Select Yes to Are you reporting a protocol violatIon today? to open the form and enter the protocol violation data. Enter the date when the violation occurred. Enter the PV data in REDCap on the Study Day corresponding to the date the PV occurred. Enter the date when the violation was identified by site research staff. Indicate whether the local qualified investigator has been made aware of this violation, Yes or No. Select one protocol violation per report : Dose delivered over a 3 day average is < 80 % prescribed Dispensing/dosing error Accidental unblinding Enrollment of a patient that does not fulfill inclusion/exclusion criteria Open label glutamine given Unapproved EN formula given Other (specify) _________________________ Indicate if there are supporting files to be emailed or faxed for this PV by selecting the appropriate response: Yes, by email (preferred) Yes, by fax No IMPORTANT: Remember to de-identify any documents before sending them. Describe the action taken by the Research Coordinator/responsible delegate to prevent violation/problem from recurring. Indicate if you have another Protocol Violation to add, Yes or No. Select Yes to open the next PV form and enter the data. Report up to 6 PVs per day. If you have more than 6 PVs to report on one study day, contact the Project Leader. 36 Protocol Violation Form Date PV occurred Are you Reporting a Protocol Violation today? Protocol Violation #1 Date Violation Discovered Randomization Number (yyyy-mm-dd) o Yes o No (yyyy-mm-dd) Is the local site investigator aware of the violation? Violation (select only one per report)

Are there supporting files to be emailed (preferred) or faxed? IMPORTANT: Remember to de-identify all documents before emailing or faxing. Action taken by Research Coordinator/Responsible Delegate Another Protocol Violation to add? Protocol Violation #2 Date Violation Discovered Is the local site investigator aware of the violation? Violation (select only one per report) Are there supporting files to be emailed (preferred) or faxed? IMPORTANT: Remember to de-identify all documents before emailing or faxing. Action taken by Research Coordinator/Responsible Delegate Another Protocol Violation to add? o Yes o No Dose delivered over a 3 day average is < 80 % prescribed Dispensing/dosing error Accidental unblinding Enrollment of a patient that does not fulfill inclusion/exclusion criteria Open label glutamine given Unapproved EN formula given Other (specify) _________________________ Yes, by email (preferred) Yes, by fax No o Yes o No (yyyy-mm-dd) o Yes o No Dose delivered over a 3 day average is < 80 % prescribed Dispensing/dosing error Accidental unblinding Enrollment of a patient that does not fulfill inclusion/exclusion criteria Open label glutamine given Unapproved EN formula given Other (specify) _________________________ Yes, by email (preferred) Yes, by fax No o Yes o No 37 Randomization Number Hospitalization Overview Instructions General Instructions Duration of Data Collection Last Successful Graft (Was the last successful graft

achieved?) ACU Stay Was Consent withdrawn/denied during this ACU stay? Did the patient die during this ACU stay? These data are collected to determine clinical outcomes related to length of stay and mortality. These data are to be collected once. Indicate whether the last successful graft was achieved by selecting Yes, No, or Not Available Consent withdrawn for data collection. If Yes, enter the date of the last successful graft in the format yyyy-mm-dd. If No, select the reason the last successful graft was never achieved: Death Withdrew Life Sustaining Therapies Discharged without receiving a graft Receiving grafts after ACU discharge (< 3 mo.) Still receiving grafts in ACU at 3 months Other, specify: __________________________ If consent was withdrawn or denied during this ACU stay, indicate by selecting 'Yes. Enter the date and time consent was withdrawn/denied and select the type of withdrawal/denial: Stop intervention, continue data collection Stop intervention, stop data collection (keep previous data) Stop intervention, stop data collection (discard previous data) Select the appropriate response to indicate if the patient died during this ACU stay, was discharged, or is still in ACU at 3 months from admission: Yes Record the death date, time, and cause of death. Note: Record the death date and time documented on the death certificate. If this information is not available, record the date and time from the physician note. If the latter is not provided, record the date and time documented in the nurses charting. Document the cause of death from a post mortem report. If this is not available, record cause of death from the death certificate. No, Patient Discharged Enter the date and time the patient was actually discharged from the ACU. No, Patient Still in ACU At 3 months Was the patient readmitted to the ACU? (before being discharged from hospital) Indicate if the patient was readmitted to your ACU from within your hospital. Yes or No. If Yes, the patient was re-admitted to your ACU from another ward in your hospital: Enter the re-admission date and time. Indicate if consent was withdrawn/denied during this ACU stay. If Yes, enter the date and time and the type of withdrawal/denial: o Stop collection (keep previous data) o Stop data collection (discard previous data) Repeat steps above for responses to Did the patient die during this ACU stay? Record up to 5 ACU admissions (including the initial admission). Once the patient is discharged from your hospital, do not record ACU re-admissions. If No, the patient was not re-admitted, complete the Hospital Stay data. 38

Randomization Number Hospitalization Overview Instructions (continued) Hospital Stay Was Consent withdrawn/denied during this Hospital stay? Hospital discharge (Did the patient die in Hospital?) d/c Time not available? Discharged to If consent was withdrawn or denied during this Hospital stay, indicate by selecting 'Yes. Enter the date and time consent was withdrawn/denied and select the type of withdrawal/denial: Stop data collection (keep previous data) Stop data collection (discard previous data) Select the appropriate response to indicate if the patient died in hospital, was discharged, or is still in hospital at 3 months from admission: Yes Record the death date, time, and cause of death. Note: Record the death date and time documented on the death certificate. If this information is not available, record the date and time from the physician note. If the latter is not provided, record the date and time documented in the nurses charting. Document the cause of death from a post mortem report. If this is not available, record cause of death from the death certificate. No, Patient Discharged Enter the date and time the patient was actually discharged from the Hospital. If the hospital discharge time is not documented, select Yes to Time not available? Select the location to which the patient was discharged: o o o o o o Ward in another hospital ACU in another hospital Long term care facility Rehabilitation unit Home Other, specify _____________________ No, Patient Still in ACU At 3 months 39 Randomization Number Hospitalization Overview LAST SUCCESSFUL GRAFT Was the last successful graft achieved? o Yes No Not Available Consent withdrawn for data collection If Yes, Date of last successful graft (yyyy-mm-dd) If No, reason last successful graft never

achieved: o Death o Withdrew Life Sustaining Therapies o Discharged without receiving a graft Receiving grafts after ACU discharge (< 3 mo.) Still receiving grafts in ACU at 3 months Other, specify: ________________________________ ACU Stay Was consent withdrawn or denied during the ACU stay? Select the type of withdrawal/denial: Date (yyyy-mm-dd) o If yes, record the date and time consent was withdrawn/denied Did the patient die in the ACU? Stop intervention, continue data collection Stop intervention, stop data collection (keep previous data) Stop intervention, stop data collection (discard previous data) o If yes, record the death date/time Was the patient re-admitted to the ACU? o If the patient discharged from the ACU, record the ACU discharge date/time o The patient was still in the ACU at 3 months o If yes, record the date and time the patient was re-admitted Date (yyyy-mm-dd) ACU Stay #2 Was consent withdrawn or denied during the ACU stay? Select the type of withdrawal/denial: Did the patient die in the ACU? Time (24 hour clock) Time (24 hour clock) o If yes, record the date and time consent was withdrawn/denied Stop data collection (keep previous data) Stop data collection (discard previous data) o If yes, record the death date/time o If the patient discharged from the ACU, record the ACU discharge date/time o The patient was still in the ACU at 3 months Was the patient re-admitted to the ACU? 40 Randomization Number

Hospitalization Overview (cont.) Hospital discharge Was consent withdrawn or denied during the ACU stay? Select the type of withdrawal/denial: Did the patient die in the hospital? If the patient was discharged from the hospital, where was the patient discharged to? Date (yyyy-mm-dd) Time (24 hour clock) o If yes, record the date and time consent was withdrawn/denied Stop data collection (keep previous data) Stop data collection (discard previous data) o If yes, record the death date/time o If the patient discharged from the hospital, record the hospital discharge date/time o The patient was still in the hospital at 3 months o Ward in another hospital o ACU in another hospital o Long term care facility o Rehabilitation unit o Home o Other (Please Specify): Cause of death: ________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ 41 Randomization Number Month 6 Survival Assessment Instructions General Information These data are collected to determine survival 6 months after the patient was admitted to the ACU. Every effort must be made to obtain survival status. Refer to the Followup Procedures manual regarding patient retention procedures. Duration of Data Collection Survival assessment is to be conducted at 6 months ( 14 days) after ACU admission. Was the Survival Status Obtained? Record whether the survival status of the patient was obtained, Yes or No. Date Survival Status Obtained If Yes, record the date of contact or information retrieval in the format yyyymm-dd. Source of information

Record the source of the survival status information. Survival Status Record the survival status of the patient, Alive or Deceased. Survival Status NOT Obtained o Patient Alternative contact person(s) (Specify relationship) Family Physician Medical Records Obituaries Internet Other (specify) _____________________________ o Alive Deceased If No, confirm that all the listed avenues to access the patient survival status were completed: o 3 attempts to contact the patient were made (mandatory) 3 attempts to contact the alternative contact person(s) were made (mandatory if applicable) Family doctor contacted (mandatory if available) No medical records on the patient available at month 6 (mandatory) Internet searches for the patient name did not reveal survival status (mandatory) Record all attempts to contact the patient and/or alternate contact person(s) on the 'Month 6 Follow-up Assessments: Contact Log' Last date known to be alive If survival status was not obtained, record the last date the patient was known to be alive. 42 Randomization Number Month 6 Survival Assessment Was the Survival Status Obtained? o Yes o No Survival Status Obtained Date of Contact/ Information retrieval (yyyy-mm-dd) Source of Information (Select one) o Patient o Alternate Contact Person (Specify relationship) _____________________ o Family Physician o Medical Records o Obituaries o Internet o Other (Please specify) ______________________ Survival Status o Alive o Deceased If deceased, is date of death known? If Yes, date of death

o Yes o No (yyyy-mm-dd) If No, last date known to be alive (yyyy-mm-dd) Survival Status NOT Obtained Confirm which of the following were completed Last date known to be alive o 3 attempts to contact the patient were made (mandatory) o 3 attempts to contact the alternate contact person(s) were made (mandatory if applicable) o Family doctor contacted (mandatory if available) o No medical records on the patient available at month 6 (mandatory) o Internet searches for the patient name did not reveal survival status (mandatory) (yyyy-mm-dd) 43 Randomization Number Month 6 Follow-up Assessments: Contact Log Instructions General Information Do NOT complete this form if Survival Status was obtained. Record all contacts and attempted contacts with the patient/alternate contact person(s) for the Month 6 follow-up assessments on this log. There must be at least 3 attempts to conduct the follow-up assessments. Completion of all 3 questionnaires is estimated to take 30 minutes. Each questionnaire may be completed on different days or at different times if need be. It is strongly recommended to schedule time in advance with the patient/alternate contact person(s) to ensure her/his availability. Duration of Data These data are collected once 6 months ( 14 days) after ACU admission. Collection Booking Follow-up Indicate if the patient/alternate person(s) was contacted in advance to book an Appointment appointment for the follow-up visit, Yes or No. If Yes, enter the date the patient/alternate person(s) contacted. If No, record the reason in the space provided. Contact Attempts Indicate who was attempted to be contacted and how many times. The appropriate number of fields will open in REDCap. o Patient o Alternate contact person(s) o Both Patient and Alternate o No attempts were made If No attempts were made to contact the patient/alternate person(s), record the reason follow-up contact was not attempted: o Missed No RC at site Other (specify) _________________________________ Date and Time of Contact Record the date and time of each contact attempt. If you cannot reach the patient/alternate contact person(s) try a different time at each attempt. Contact Methods Record all methods used to contact the patient/alternate person(s). Alternate Contact

Relationship to Patient Record the relationship of the alternate contact person to the patient, if Other specify in the space provide. 44 Randomization Number Month 6 Follow-up Assessments: Contact Log Was the patient/alternate(s) contacted in advance to book an appointment for the follow-up visit? Booking Month 6 Follow-up (should be at least 2 weeks in advanced) o Yes o No Date patient/alternate contacted (yyyy-mm-dd) Reason appointment not booked Who did you contact or attempt to contact for this follow-up? If no attempts, Reason follow-up not attempted: Attempt 1 o Patient o Alternate contact person(s) o Both Patient and Alternate o No attempts were made o Missed o No RC (research coordinator) at site o Other (specify) _________________________ Attempt 2 Attempt 3 Date of Contact (yyyy-mm-dd) Time (hh:mm) o In person with patient o Called patient (cell) o Called patient (work) o Called patient (home) o Other (specify) o In person with patient o Called patient (cell) o Called patient (work) o Called patient (home) o Other (specify) o In person with patient o Called patient (cell) o Called patient (work) o Called patient (home) o Other (specify) Alternate contact person(s) method (Select all that apply) o In person with alt. o Called alt. (cell) o Called alt. (work) o Called alt. (home) o Other (specify)

o In person with alt. o Called alt. (cell) o Called alt. (work) o Called alt. (home) o Other (specify) o In person with alt. o Called alt. (cell) o Called alt. (work) o Called alt. (home) o Other (specify) Relationship of alternate contact person(s) to patient (Select all that apply) o Spouse/Partner o Parent o Child o Friend o Other (specify) o Spouse/Partner o Parent o Child o Friend o Other (specify) o Spouse/Partner o Parent o Child o Friend o Other (specify) Patient Contact Method (Select all that apply) 45 Randomization Number Month 6 Follow-up Assessment Questionnaires General Information These data are collected to assess the patients health-related quality of life and activities of daily living at the 6 month follow up interval. Refer to the Follow-up Procedures manual regarding patient retention procedures and suggested telephone scripts. Duration of Data Collection SF-36, ADL, and IADL status assessments are to be conducted at 6 months ( 14 days) after ACU admission. Every effort must be made to complete these questionnaires. Questionnaire completed? NOTE: Late data is better than missing data. For each, indicate if the questionnaire was completed, Yes, or No. If Yes, enter the date completed and by whom, Patient or Alternate. If No, indicate the reason: o Deceased (Record date on the survival assessment) o Patient Refused o Alternate Refused o Both Patient and Alternate Refused o Not able to reach patient and/or alternate o Withdrew

o Missed o Other (specify): _________________________ SF-36 Katz ADL Lawton IADL Maintain Worksheets Read the explanation at the top of the survey to the patient. Ensure the patient understands the responses should reflect her/his views about her/his own health. Remember not to interpret the questions for the patient. Each question means what he/ she thinks it means, there is no right or wrong answer. Read each question to the patient followed by the response options. Record the patients response on the questionnaire worksheet. The Katz ADL is used to assess the level of patient independence related to self-care. The patients responses should reflect what he/she is actually able to do, not what they think they might be able to do under ideal circumstances. Read the definitions of Independence and Dependence to the patient as stated on the top of the Katz ADL form. Read each of the 6 activities to the patient followed by the independent and dependent descriptions. Allow the patient to make her/his own determination. Based on the patients response, record either 1 or 0 in the space provided for each activity. The Lawton IADL is used to assess the level of patient functional ability related to domestic and community activities. The patients responses should reflect her/his highest functional level, not the activities they actual do. For example, if a patient is not the person in the household that does the laundry, but the patient is capable of doing her/his own laundry independently select Does personal laundry completely. Read each of the 8 activities to the patient followed by the response options. Remind the patient to indicate her/his highest functional ability. Allow the patient to make her/his own determination. Circle the corresponding number on the form. Keep the completed worksheets with the patient study files, these are your source documentation. 46 Randomization Number SF-36 47 Randomization Number SF-36 cont. 48 Randomization Number SF-36 cont. 49 Randomization Number SF-36 cont. 50 Enrollment Number SF-36 cont. 51 Randomization Number Katz Index of Independence in Activities of Daily Living

52 Randomization Number Lawton Instrumental Activities of Daily Living (IADLs) 53 Randomization Number Lawton IADLs cont. 54 Randomization Number Investigator Confirmation Instructions General Instructions When all the data collection has been completed, including hospitalization overview, the Site Investigator is to sign & date the Investigator Confirmation Form to attest to the following: The data collection was conducted under her/his supervision according to the protocol The data and statement are complete and accurate to the best of her/his knowledge. Once the REDCAP generated Investigator Confirmation Form has been signed and dated, please send the completed form to: Maureen Dansereau Clinical Evaluation Research Unit [email protected] 55 Randomization Number Investigator Confirmation Form (Go to REDCAP for e-version) The data collected in the RE-ENERGIZE Case Report Forms were collected in accordance with the study protocol and established procedures. The data was collected under my supervision. The data and statement are complete and accurate to the best of my knowledge. Full Name of Investigator Signature of the Investigator Date (yyyy-mm-dd) 56 Enrollment Number APPENDIX 1 Lund-Browder Diagram 57

Recently Viewed Presentations

  • Prezentacja programu PowerPoint

    Prezentacja programu PowerPoint

    By 1965 he had begun to lead the Beatles into folk rock through his interest in the Byrds and Bob Dylan, and towards Indian classical music through his use of the sitar on "Norwegian Woo"(This Bird Has Flown)". ... He...
  • Module Two - Television - WordPress.com

    Module Two - Television - WordPress.com

    The concept of Audience is an important element in media literacy. A room full of people can watch the same show and interpret it many different ways.
  • SciShow - PC&#92;|MAC

    SciShow - PC\|MAC

    SciShow: What happens if you get struck by lightning. Questions. 1. What is the chance that you will get struck by lightning in your lifetime? 2. How many types of lightning strikes exist?
  • Bristol Softball Association

    Bristol Softball Association

    Benedict Bermange Bristol Softball Association Benedict Bermange * Why keep score? Be involved Keep a record of what happened Keep track of the score and outs during a game Analyse team performance Maintain player statistics Improve batting, pitching and baserunning...
  • Introduction and Decalogue - St. Mary&#x27;s University, Texas

    Introduction and Decalogue - St. Mary's University, Texas

    Early (premodern) Modern Postmodern Cryptic - scripture means much more than what it appears to mean, has hidden meanings, might "imply" much more than what it says Relevant - scripture is about us and our time, not the times in...
  • When all the forces being applied to an

    When all the forces being applied to an

    Acceleration from multiple forces Three people are pulling on a wagon applying forces of 100 N, 150 N, and 200 N. Determine the acceleration and the direction the wagon moves. ... The people are standing on a rug. Someone nearby...
  • Germany and Austria - Illinois Wesleyan University

    Germany and Austria - Illinois Wesleyan University

    Germany and Austria Robert Kauffman European Economic Integration: Country Presentation Monday, May 9th, 2005 Location General Information Area 357,021 sq km Population 82,431,390 (2005 est.) 231 ppl/sq km (est. 2005) Pop.
  • Doctrinal Mastery

    Doctrinal Mastery

    A.S.K "By contrast, I'm aware of another missionary who, knowing her unconfessed sin from before her mission would surely cause her to be sent home early, made her own plan to work extra hard during her mission and confess to...