The RE-ENERGIZE study: a RandomisEd trial of ENtERal Glutamine to minimIZE thermal injury

Not Applicable

Completed

• Conditions: Severe thermal burn injuries; Injury, Occupational Diseases, Poisoning; Burn injuries

• Registration Number: ISRCTN92905442
• Lead Sponsor: Clinical Evaluation Research Unit (CERU) (Canada)

Brief Summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29799545 [added 13/03/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-20
• Study Completion: 2012-06-01
• Last Update Posted: 1 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Current inclusion criteria as of 21/03/2012
1. Total Burn Surface Area (TBSA):
TBSA = 20% for patients ages 18 - 59 years OR
TBSA = 10% for patients ages 60 - 80 years
2. Deep 2nd and/or 3rd degree burns requiring grafting
3. Age + TBSA = 40-119

Previous inclusion criteria
1. Age + total burn surface area (TBSA) = 60 - 120 (upper limit not included)
2. Deep 2nd and/or 3rd degree burns
3. TBSA greater than or equal to 20%

Exclusion Criteria

Current exclusion criteria as of 21/03/2012
1. > 72 hrs from admission to ICU to time of consent
2. Patients > 80 yrs or < 18 yrs of age
3. Liver cirrhosis - Child s class C liver disease
4. Pregnancy
5. Absolute contra-indication for EN (intestinal occlusion or perforation, abdominal injury)
6. Patients admitted > 48 hrs post burn (for patients that receive standardized burn care and resuscitation
prior to admission to ICU, this exclusion criteria may be extended to ?Patients admitted > 96 hrs post
burn; if this is the case consent must be obtained within 24 hrs of admission to burn ICU according to
the judgement of the Site Investigator)
7. Patients with injuries from high voltage electrical shock
8. Patients who are moribund
9. Patients with BMI < 18 or > 50
10. Enrollment in another industry sponsored ICU intervention study (co-enrollment in academic studies will
be considered on a case by case basis)
11. Received glutamine supplement for > 24 hrs prior to randomization
12. Known allergy to maltodextrin, corn starch, corn, or corn products

Previous exclusion criteria
1. Greater than 48 hours from admission to intensive care unit (ICU) to time of consent
2. Patients older than 80 years or younger than 18 years of age (age of maturity for an eligible patient to obtain consent is 18 years in Canada and in the United States of America)
3. Liver cirrhosis: Child's class C liver disease
4. Pregnancy (urine/blood tests for pregnancy will be done on all women of childbearing age by each site as part of standard of ICU practice)
5. Associated multiple fractures or severe head trauma
6. Absolute contra-indication for enteral nutrition (EN): intestinal occlusion or perforation, abdominal injury
7. Patients admitted more than 48 hours post-burn (for patients that receive standardised burn care and resuscitation prior to admission to ICU, this exclusion criteria may be extended to Patients admitted more than more than 72 hours post-burn according to the judgement of the Site Investigator)
8. Patients with injuries from high voltage electrical shock
9. Patients who are moribund
10. Patients with extreme body sizes: body mass index (BMI) less than 18 or greater than 50 kg/m^2
11. Enrolment in another industry sponsored ICU intervention study (co-enrolment in academic studies will be considered on a case by case basis)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death: Hospital mortality recorded until complete healing, defined as 7 days after the last grafting procedure.