Status:
UNKNOWN
The RE-ENERGIZE Study: RandomizEd Trial of ENtERal Glutamine to minimIZE Thermal Injury
Lead Sponsor:
Daren K. Heyland
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Burns
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to test the following hypotheses: 1. Enteral glutamine administration decreases in-hospital mortality in adult patients with severe thermal burn injuries. 2. Enteral glut...
Detailed Description
Burn injuries represent a public health problem worldwide, ranked fourth in all injuries and are among the leading cause of disability adjusted life years in low and middle-income countries. More than...
Eligibility Criteria
Inclusion
- Deep 2nd and/or 3rd degree burns requiring grafting
- Patient meets one of the following 4 criteria:
- Patients 18 - 39 years of age with ≥ 20% TBSA\* burn
- Patients 18 - 39 years of age with ≥ 15% TBSA\* burn and with inhalation injury
- Patients 40 - 59 years of age with ≥ 15% TBSA\* burn
- Patients ≥ 60 years of age ≥ 10% TBSA\* \*TBSA - Total Body Surface Area
Exclusion
- \> 72 hrs from admission to ICU to time of consent.
- Patients younger than 18 years of age.
- a) Patients without known renal disease and renal dysfunction defined as a serum creatinine \>171 µmol/L 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).
- b) Patients with acute on chronic renal failure (pre-dialysis) with an absolute increase of \>80 µmol/L from baseline or pre-admission creatinine or a urine output of \<500 mL/last 24 hours (or 80 mL/last 4 hours).
- c) Patients with chronic renal failure on dialysis will be excluded.
- Liver cirrhosis - Child-Pugh class C liver disease
- Pregnant or lactating females.
- Contra-indication for EN: intestinal occlusion or perforation, intra-abdominal injury.
- Patients with injuries from high voltage electrical contact.
- Patients who are moribund (not expected to survive the next 72 hours).
- Patients with extreme body sizes: BMI \< 18 or \> 50
- Enrollment in another industry sponsored ICU intervention study.
- Received glutamine supplement for \> 24 hrs prior to randomization
- Known allergy to maltodextrin, corn starch, corn, corn products or glutamine.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
1201 Patients enrolled
Trial Details
Trial ID
NCT00985205
Start Date
December 1 2010
End Date
December 1 2021
Last Update
December 30 2021
Active Locations (53)
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1
University of South Alabama Medical Center
Mobile, Alabama, United States, 36609
2
Arizona Burn Center at Maricopa Medical Center
Phoenix, Arizona, United States, 85008
3
Southern California Regional Burn Ctr at LAC & USC Med. Ctr.
Los Angeles, California, United States, 90089-9235
4
Shriners Hospitals for Children Northern California
Sacramento, California, United States, 95817