The RE-ENERGIZE Study: RandomizEd Trial of ENtERal Glutamine to minimIZE Thermal Injury

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Burns

In brief

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 glutamine administration decreases hospital-acquired blood stream infections from Gram negative organisms and length of stay in ICU and hospital for adult patients with severe thermal burn injuries. 3. Enteral glutamine administration will improve the physical function of surviving burn injured patients and reduce their cost of care. The objectives of this trial are to determine the overall treatment effect and safety of glutamine in burn patients. Specifically, the investigators want to assess the following outcomes in a sample of 1200 patients in 80 sites: 1. In patients with severe, life-threatening burn injury, what is the effect of enteral glutamine on time to discharge alive from hospital 2. In patients with severe, life-threatening burn injury, what is the effect of enteral glutamine on 6 month mortality, hospital-acquired blood stream infections from Gram negative organisms, hospital mortality, duration of stay in ICU and hospital, health-related quality of life, and health care resources?

Key facts

Study ID

NCT00985205

Run by

Daren K. Heyland

People needed

1201

Starts

2010-12-01

Expected to finish

2021-12-01

Last updated by the study team

2021-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• > 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.

Where it is running

• Arizona Burn Center at Maricopa Medical Center — Phoenix, Arizona, United States
• Southern California Regional Burn Ctr at LAC & USC Med. Ctr. — Los Angeles, California, United States
• Shriners Hospitals for Children Northern California — Sacramento, California, United States
• Department of Anesthesiology, University of Colorado — Aurora, Colorado, United States
• North Colorado Medical Center - Banner Health — Greeley, Colorado, United States
• Connecticut Burn Center — Bridgeport, Connecticut, United States
• The Burn Center at Washington Hospital Center — Washington D.C., District of Columbia, United States
• Shands Burn Center at the University of Florida — Gainesville, Florida, United States
• University of South Florida/Tampa Gen. Hosp. Reg. Burn Center, FL — Tampa, Florida, United States
• Joseph M Still Burn Center — Augusta, Georgia, United States
• Department of Surgery University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• Mercy Hospital St. Louis — St Louis, Missouri, United States
• CHI St.Elizabeth Regional Burn Center — Lincoln, Nebraska, United States
• The Nebraska Medical Center — Omaha, Nebraska, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Akron's Children's Hospital, Paul & Carol David Foundation — Akron, Ohio, United States
• The Ohio State University Wexnar Medical Center — Columbus, Ohio, United States
• Legacy Emmanuel Hospital & Health Center — Portland, Oregon, United States
• The Western Pennsylvania Hospital Burn Center — Pittsburgh, Pennsylvania, United States
• Firefighters' Regional Burn Center TN, University of Tennesse Health & Sciences Center — Memphis, Tennessee, United States
• University of Texas Southwestern — Dallas, Texas, United States
• JBSA Fort Sam Houston — Fort Sam Houston, Texas, United States
• University of Texas Medical Branch — Galveston, Texas, United States
• Memorial Hermann/UTHSC — Houston, Texas, United States
• University of South Alabama Medical Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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