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

NCT00985205 | Unknown Phase 3 DMC

• 2 other identifiers: RE-ENERGIZECIHR # 190808
• Study Type: interventional
• Target: 1,201
• Locations: 14 countries
• Sites: 53

Brief Summary

The purpose of this study is to test the following hypotheses:

1. 1.Enteral glutamine administration decreases in-hospital mortality in adult patients with severe thermal burn injuries.
2. 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. 3.Enteral glutamine administration will improve the physical function of surviving burn injured patients and reduce their cost of care.
4. 4.In patients with severe, life-threatening burn injury, what is the effect of enteral glutamine on time to discharge alive from hospital
5. 5.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?

Conditions

Burns

Keywords

Randomized Clinical Trial; Glutamine; Themal Burn Injuries; Nutrition; Outcome Assessment; Critical Care; Total Body Surface Area

Outcome Measures

Primary Outcomes (1)

• Time to Discharge Alive

  3 months

Secondary Outcomes (1)

• 6 Month Mortality

  6 Months

Other Outcomes (6)

• Health-Related Quality of Life - in particular the physical function domain of the SF-36, ADL, and IADL questionnaires.

  6 Month

• Incidence of acquired bacteremia due to Gram negative organisms

  3 Months

• Hospital Mortality

  3 Months

Study Arms (2)

Enteral Glutamine

EXPERIMENTAL

0.5 g/kg/day mixed in water and given via nasogastric or feeding tube as boluses q 4 hrs or TID or QID if po

Dietary Supplement: Enteral Glutamine

Placebo

PLACEBO COMPARATOR

Mixed in with water and given via nasogastric or feeding tube as boluses q 4hrs or TID or QID if po

Dietary Supplement: Placebo

Interventions

Enteral Glutamine DIETARY_SUPPLEMENT

0.5g/kg/day powdered glutamine to be mixed in with water and given via nasogastric or feeding tube q4 hrs or TID or QID if po.

Also known as: Glutamine

Enteral Glutamine

Placebo DIETARY_SUPPLEMENT

Maltodextrin mixed with water given via NG or feeding tube Q 4 hours or TID or QID if po.

Also known as: Maltodextrin

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Daren K. Heyland: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (53)

University of South Alabama Medical Center

Mobile, Alabama, 36609, United States

Location

Arizona Burn Center at Maricopa Medical Center

Phoenix, Arizona, 85008, United States

Location

Southern California Regional Burn Ctr at LAC & USC Med. Ctr.

Los Angeles, California, 90089-9235, United States

Location

Shriners Hospitals for Children Northern California

Sacramento, California, 95817, United States

Location

Department of Anesthesiology, University of Colorado

Aurora, Colorado, 80045, United States

Location

North Colorado Medical Center - Banner Health

Greeley, Colorado, 80631, United States

Location

Connecticut Burn Center

Bridgeport, Connecticut, 06610, United States

Location

The Burn Center at Washington Hospital Center

Washington D.C., District of Columbia, 20782, United States

Location

Shands Burn Center at the University of Florida

Gainesville, Florida, 32610, United States

Location

University of South Florida/Tampa Gen. Hosp. Reg. Burn Center, FL

Tampa, Florida, 33606, United States

Location

Joseph M Still Burn Center

Augusta, Georgia, 30909, United States

Location

Department of Surgery University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Mercy Hospital St. Louis

St Louis, Missouri, 63141, United States

Location

CHI St.Elizabeth Regional Burn Center

Lincoln, Nebraska, 68150, United States

Location

The Nebraska Medical Center

Omaha, Nebraska, 68198-7835, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Akron's Children's Hospital, Paul & Carol David Foundation

Akron, Ohio, 44308-1062, United States

Location

The Ohio State University Wexnar Medical Center

Columbus, Ohio, 43210, United States

Location

Legacy Emmanuel Hospital & Health Center

Portland, Oregon, 97232, United States

Location

The Western Pennsylvania Hospital Burn Center

Pittsburgh, Pennsylvania, 15224, United States

Location

Firefighters' Regional Burn Center TN, University of Tennesse Health & Sciences Center

Memphis, Tennessee, 38102, United States

Location

University of Texas Southwestern

Dallas, Texas, 8563, United States

Location

JBSA Fort Sam Houston

Fort Sam Houston, Texas, 78234-7767, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Memorial Hermann/UTHSC

Houston, Texas, 77030, United States

Location

Harbourview Medical Center

Seattle, Washington, 98195-9796, United States

Location

Columbia-St. Mary's, Milwaukee, Wi

Milwaukee, Wisconsin, 53202, United States

Location

Medical University of Graz

Graz, Styria, Austria

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

University Hospital of Liège

Liège, 4000, Belgium

Location

The Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403-000, Brazil

Location

Foothills Medical Centre

Calgary, Alberta, Canada

Location

HHS/Hamilton Firefighters Burn Unit

Hamilton, Ontario, L8L 2X2, Canada

Location

Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

CHUM/Centre des Grands Brules

Montreal, Quebec, H2X 0A9, Canada

Location

HEJ/Centre des Grands Brules

Québec, Canada

Location

Instituto Tecnologico de Santo Domingo

Santo Domingo, 10602, Dominican Republic

Location

RWTH Aachen University

Aachen, North Rhine-Westphalia, 52062, Germany

Location

Berufsgenossenschaftliche Unfallklinik Ludwigshafen

Ludwigshafen, Rhein, Germany

Location

A.O.U. Citta della Salute e della Scienza di Torino

Torino, TO, 10126, Italy

Location

Centro Nacional de Quemaduras y Cirugia Reconstructiva

Asunción, Paraguay

Location

Singapore General Hospital

Singapore, Singapore

Location

Hospital Universitario La Fe

Valencia, 46026, Spain

Location

Uppsala University Hospital

Uppsala, 75124, Sweden

Location

Siriraj Hospital, Divison of Trauma Surgery, Mahidol University

Bangkok, NOI, Thailand

Location

King Chulalongkorn Memorial Hospital Chulalongkorn University

Bangkok, Pathumwan, 1873, Thailand

Location

Khon Kaen University

Nonthaburi, 40002, Thailand

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, Edgbaston, B15 2GW, United Kingdom

Location

St Helens & Knowsley Teaching Hospitals

Liverpool, England, United Kingdom

Location

Chelsea and Westminster Hospital

London, England, SW10 9NH, United Kingdom

Location

Newcastle upon Tyne Hospitals

Newcastle upon Tyne, England, NE7 7DN, United Kingdom

Location

Manchester University NHSFT

Manchester, London, M13 9WL, United Kingdom

Location

Pinderfields Hospital, Mid Yorkshire NHS Trust

London, West Yorkshire, United Kingdom

Location

Related Publications (5)

• Garrel D, Patenaude J, Nedelec B, Samson L, Dorais J, Champoux J, D'Elia M, Bernier J. Decreased mortality and infectious morbidity in adult burn patients given enteral glutamine supplements: a prospective, controlled, randomized clinical trial. Crit Care Med. 2003 Oct;31(10):2444-9. doi: 10.1097/01.CCM.0000084848.63691.1E.

  PMID: 14530749 BACKGROUND

• Zhou YP, Jiang ZM, Sun YH, Wang XR, Ma EL, Wilmore D. The effect of supplemental enteral glutamine on plasma levels, gut function, and outcome in severe burns: a randomized, double-blind, controlled clinical trial. JPEN J Parenter Enteral Nutr. 2003 Jul-Aug;27(4):241-5. doi: 10.1177/0148607103027004241.

  PMID: 12903886 BACKGROUND

• Peng X, Yan H, You Z, Wang P, Wang S. Effects of enteral supplementation with glutamine granules on intestinal mucosal barrier function in severe burned patients. Burns. 2004 Mar;30(2):135-9. doi: 10.1016/j.burns.2003.09.032.

  PMID: 15019120 BACKGROUND

• Heyland DK, Wibbenmeyer L, Pollack J, Friedman B, Turgeon AF, Eshraghi N, Jeschke MG, Belisle S, Grau D, Mandell S, Velamuri SR, Hundeshagen G, Moiemen N, Shokrollahi K, Foster K, Huss F, Collins D, Savetamal A, Gurney JM, Depetris N, Stoppe C, Ortiz-Reyes L, Garrel D, Day AG; RE-ENERGIZE Trial Team. A Randomized Trial of Enteral Glutamine for Treatment of Burn Injuries. N Engl J Med. 2022 Sep 15;387(11):1001-1010. doi: 10.1056/NEJMoa2203364. Epub 2022 Sep 9.

  PMID: 36082909 DERIVED

• Heyland DK, Wischmeyer P, Jeschke MG, Wibbenmeyer L, Turgeon AF, Stelfox HT, Day AG, Garrel D. A RandomizEd trial of ENtERal Glutamine to minimIZE thermal injury (The RE-ENERGIZE Trial): a clinical trial protocol. Scars Burn Heal. 2017 Dec 12;3:2059513117745241. doi: 10.1177/2059513117745241. eCollection 2017 Jan-Dec.

  PMID: 29799545 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Burns

Interventions

Glutamine; maltodextrin

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Officials

• Daren Heyland, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 25, 2009
• First Posted: September 28, 2009
• Study Start: December 1, 2010
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 30, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); PA (1); DE (2); CA (5); SG (1); ES (1); SE (1); TH (3); GB (6); AU (1); US (27); BR (1); DO (1); IT (1)