A RandomizEd trial of ENtERal Glutamine to minimIZE thermal injury (The RE-ENERGIZE Trial): a clinical trial protocol
Background: Burn injury represents a significant public health problem worldwide. More than in any other injury, the inflammation and catabolism associated with severe burns can exacerbate nutrient deficiencies resulting in impaired immune function and increased risk of developing infection, organ d...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2017-12-01
|
| Series: | Scars, Burns & Healing |
| Online Access: | https://doi.org/10.1177/2059513117745241 |
| _version_ | 1818529794298478592 |
|---|---|
| author | Daren K. Heyland Paul Wischmeyer Marc G. Jeschke Lucy Wibbenmeyer Alexis F. Turgeon Henry T. Stelfox Andrew G. Day Dominique Garrel |
| author_facet | Daren K. Heyland Paul Wischmeyer Marc G. Jeschke Lucy Wibbenmeyer Alexis F. Turgeon Henry T. Stelfox Andrew G. Day Dominique Garrel |
| author_sort | Daren K. Heyland |
| collection | DOAJ |
| description | Background: Burn injury represents a significant public health problem worldwide. More than in any other injury, the inflammation and catabolism associated with severe burns can exacerbate nutrient deficiencies resulting in impaired immune function and increased risk of developing infection, organ dysfunction and death. Consequently, over the last few decades numerous trials have evaluated the impact of different nutritional strategies in severe burn injury. Glutamine is of particular interest, as it appears vital for a number of key stress-response pathways in serious illness. The purpose of the current manuscript is to provide the rationale and protocol for a large clinical trial of supplemental enteral glutamine in 2700 severe burn-injured patients. Methods: We propose a multicentre, double-blind, pragmatic, randomized, clinical trial involving 80 tertiary intensive care unit (ICU) burn centres worldwide. We aim to enrol patients with deep second- and/or third-degree burns at moderate or high risk for death. We will exclude patients admitted > 72 h before screening and patients with advanced liver and kidney disease. The study intervention consists of enteral glutamine 0.5 g/kg/day vs. isocaloric maltodextran control delivered enterally. Primary outcome will be six-month mortality. Key secondary outcomes include time to discharge alive from hospital, ICU and hospital mortality, length of stay and health-related quality of life at six months. Significance: This study will be the first large international multicentre trial examining the effects of glutamine in burn patients. Negative or positive, the results of this trial will inform the clinical practice of burns care worldwide. Clinicaltrials.gov ID #NCT00985205 |
| first_indexed | 2024-12-11T17:11:30Z |
| format | Article |
| id | doaj.art-1d8d8c16699749e7a3d2881a752a7ef2 |
| institution | Directory Open Access Journal |
| issn | 2059-5131 |
| language | English |
| last_indexed | 2024-12-11T17:11:30Z |
| publishDate | 2017-12-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Scars, Burns & Healing |
| spelling | doaj.art-1d8d8c16699749e7a3d2881a752a7ef22022-12-22T00:57:30ZengSAGE PublishingScars, Burns & Healing2059-51312017-12-01310.1177/2059513117745241A RandomizEd trial of ENtERal Glutamine to minimIZE thermal injury (The RE-ENERGIZE Trial): a clinical trial protocolDaren K. Heyland0Paul Wischmeyer1Marc G. Jeschke2Lucy Wibbenmeyer3Alexis F. Turgeon4Henry T. Stelfox5Andrew G. Day6Dominique Garrel7Clinical Evaluation Research Unit, Kingston General Hospital, Kingston, ON, CanadaDepartment of Anesthesiology and Surgery, Duke Clinical Research Institute. Duke University School of Medicine, Durham, NC, USARoss Tilley Burn Centre, Sunnybrook Health Sciences Centre, Sunnybrook Research Institute Department of Surgery, Division of Plastic Surgery, Department of Immunology University of Toronto, Toronto, ON, CanadaUniversity of Iowa Hospitals and Clinics, Iowa City, IA, USADepartment of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine, Université Laval, Québec City, QC, CanadaDepartment of Critical Care Medicine and O’Brien Institute for Public Health, University of Calgary, Calgary, AB, CanadaDepartment of Public Health Sciences, Queen’s University, Kingston, ON, CanadaDepartment of Nutrition, Faculty of Medicine, University of Montreal, Montreal, QC, CanadaBackground: Burn injury represents a significant public health problem worldwide. More than in any other injury, the inflammation and catabolism associated with severe burns can exacerbate nutrient deficiencies resulting in impaired immune function and increased risk of developing infection, organ dysfunction and death. Consequently, over the last few decades numerous trials have evaluated the impact of different nutritional strategies in severe burn injury. Glutamine is of particular interest, as it appears vital for a number of key stress-response pathways in serious illness. The purpose of the current manuscript is to provide the rationale and protocol for a large clinical trial of supplemental enteral glutamine in 2700 severe burn-injured patients. Methods: We propose a multicentre, double-blind, pragmatic, randomized, clinical trial involving 80 tertiary intensive care unit (ICU) burn centres worldwide. We aim to enrol patients with deep second- and/or third-degree burns at moderate or high risk for death. We will exclude patients admitted > 72 h before screening and patients with advanced liver and kidney disease. The study intervention consists of enteral glutamine 0.5 g/kg/day vs. isocaloric maltodextran control delivered enterally. Primary outcome will be six-month mortality. Key secondary outcomes include time to discharge alive from hospital, ICU and hospital mortality, length of stay and health-related quality of life at six months. Significance: This study will be the first large international multicentre trial examining the effects of glutamine in burn patients. Negative or positive, the results of this trial will inform the clinical practice of burns care worldwide. Clinicaltrials.gov ID #NCT00985205https://doi.org/10.1177/2059513117745241 |
| spellingShingle | Daren K. Heyland Paul Wischmeyer Marc G. Jeschke Lucy Wibbenmeyer Alexis F. Turgeon Henry T. Stelfox Andrew G. Day Dominique Garrel A RandomizEd trial of ENtERal Glutamine to minimIZE thermal injury (The RE-ENERGIZE Trial): a clinical trial protocol Scars, Burns & Healing |
| title | A RandomizEd trial of ENtERal Glutamine to minimIZE thermal injury (The RE-ENERGIZE Trial): a clinical trial protocol |
| title_full | A RandomizEd trial of ENtERal Glutamine to minimIZE thermal injury (The RE-ENERGIZE Trial): a clinical trial protocol |
| title_fullStr | A RandomizEd trial of ENtERal Glutamine to minimIZE thermal injury (The RE-ENERGIZE Trial): a clinical trial protocol |
| title_full_unstemmed | A RandomizEd trial of ENtERal Glutamine to minimIZE thermal injury (The RE-ENERGIZE Trial): a clinical trial protocol |
| title_short | A RandomizEd trial of ENtERal Glutamine to minimIZE thermal injury (The RE-ENERGIZE Trial): a clinical trial protocol |
| title_sort | randomized trial of enteral glutamine to minimize thermal injury the re energize trial a clinical trial protocol |
| url | https://doi.org/10.1177/2059513117745241 |
| work_keys_str_mv | AT darenkheyland arandomizedtrialofenteralglutaminetominimizethermalinjurythereenergizetrialaclinicaltrialprotocol AT paulwischmeyer arandomizedtrialofenteralglutaminetominimizethermalinjurythereenergizetrialaclinicaltrialprotocol AT marcgjeschke arandomizedtrialofenteralglutaminetominimizethermalinjurythereenergizetrialaclinicaltrialprotocol AT lucywibbenmeyer arandomizedtrialofenteralglutaminetominimizethermalinjurythereenergizetrialaclinicaltrialprotocol AT alexisfturgeon arandomizedtrialofenteralglutaminetominimizethermalinjurythereenergizetrialaclinicaltrialprotocol AT henrytstelfox arandomizedtrialofenteralglutaminetominimizethermalinjurythereenergizetrialaclinicaltrialprotocol AT andrewgday arandomizedtrialofenteralglutaminetominimizethermalinjurythereenergizetrialaclinicaltrialprotocol AT dominiquegarrel arandomizedtrialofenteralglutaminetominimizethermalinjurythereenergizetrialaclinicaltrialprotocol AT darenkheyland randomizedtrialofenteralglutaminetominimizethermalinjurythereenergizetrialaclinicaltrialprotocol AT paulwischmeyer randomizedtrialofenteralglutaminetominimizethermalinjurythereenergizetrialaclinicaltrialprotocol AT marcgjeschke randomizedtrialofenteralglutaminetominimizethermalinjurythereenergizetrialaclinicaltrialprotocol AT lucywibbenmeyer randomizedtrialofenteralglutaminetominimizethermalinjurythereenergizetrialaclinicaltrialprotocol AT alexisfturgeon randomizedtrialofenteralglutaminetominimizethermalinjurythereenergizetrialaclinicaltrialprotocol AT henrytstelfox randomizedtrialofenteralglutaminetominimizethermalinjurythereenergizetrialaclinicaltrialprotocol AT andrewgday randomizedtrialofenteralglutaminetominimizethermalinjurythereenergizetrialaclinicaltrialprotocol AT dominiquegarrel randomizedtrialofenteralglutaminetominimizethermalinjurythereenergizetrialaclinicaltrialprotocol |