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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...

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Autores principales: Heyland, Daren K., Wischmeyer, Paul, Jeschke, Marc G., Wibbenmeyer, Lucy, Turgeon, Alexis F., Stelfox, Henry T., Day, Andrew G., Garrel, Dominique
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5965329/
https://www.ncbi.nlm.nih.gov/pubmed/29799545
http://dx.doi.org/10.1177/2059513117745241
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author Heyland, Daren K.
Wischmeyer, Paul
Jeschke, Marc G.
Wibbenmeyer, Lucy
Turgeon, Alexis F.
Stelfox, Henry T.
Day, Andrew G.
Garrel, Dominique
author_facet Heyland, Daren K.
Wischmeyer, Paul
Jeschke, Marc G.
Wibbenmeyer, Lucy
Turgeon, Alexis F.
Stelfox, Henry T.
Day, Andrew G.
Garrel, Dominique
author_sort Heyland, Daren K.
collection PubMed
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
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spelling pubmed-59653292018-05-24 A RandomizEd trial of ENtERal Glutamine to minimIZE thermal injury (The RE-ENERGIZE Trial): a clinical trial protocol Heyland, Daren K. Wischmeyer, Paul Jeschke, Marc G. Wibbenmeyer, Lucy Turgeon, Alexis F. Stelfox, Henry T. Day, Andrew G. Garrel, Dominique Scars Burn Heal Original Article 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 SAGE Publications 2017-12-12 /pmc/articles/PMC5965329/ /pubmed/29799545 http://dx.doi.org/10.1177/2059513117745241 Text en © The Author(s) 2017 http://creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page(https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Original Article
Heyland, Daren K.
Wischmeyer, Paul
Jeschke, Marc G.
Wibbenmeyer, Lucy
Turgeon, Alexis F.
Stelfox, Henry T.
Day, Andrew G.
Garrel, Dominique
A RandomizEd trial of ENtERal Glutamine to minimIZE thermal injury (The RE-ENERGIZE Trial): a clinical trial protocol
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
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5965329/
https://www.ncbi.nlm.nih.gov/pubmed/29799545
http://dx.doi.org/10.1177/2059513117745241
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