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Effect of intravenous GLutamine supplementation IN Trauma patients receiving enteral nutrition study protocol (GLINT Study): a prospective, blinded, randomised, placebo-controlled clinical trial

BACKGROUND: Trauma patients are characterised by alterations in the immune system, increased exposure to infectious complications, sepsis and potentially organ failure and death. Glutamine supplementation to parenteral nutrition has been proven to be associated with improved clinical outcomes. Howev...

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Autores principales: Al Balushi, Ruqaiya M, Paratz, Jennifer D, Cohen, Jeremy, Banks, Merrilyn, Dulhunty, Joel, Roberts, Jason A, Lipman, Jeffrey
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Group 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3221292/
https://www.ncbi.nlm.nih.gov/pubmed/22102646
http://dx.doi.org/10.1136/bmjopen-2011-000334
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author Al Balushi, Ruqaiya M
Paratz, Jennifer D
Cohen, Jeremy
Banks, Merrilyn
Dulhunty, Joel
Roberts, Jason A
Lipman, Jeffrey
author_facet Al Balushi, Ruqaiya M
Paratz, Jennifer D
Cohen, Jeremy
Banks, Merrilyn
Dulhunty, Joel
Roberts, Jason A
Lipman, Jeffrey
author_sort Al Balushi, Ruqaiya M
collection PubMed
description BACKGROUND: Trauma patients are characterised by alterations in the immune system, increased exposure to infectious complications, sepsis and potentially organ failure and death. Glutamine supplementation to parenteral nutrition has been proven to be associated with improved clinical outcomes. However, glutamine supplementation in patients receiving enteral nutrition and its best route are still controversial. Previous trials have been limited by a small sample size, use of surrogate outcomes or a limited period of supplementation. The aim of this trial is to investigate if intravenous glutamine supplementation to trauma patients receiving enteral nutrition is associated with improved clinical outcomes in terms of decreased organ dysfunction, infectious complications and other secondary outcomes. METHODS/DESIGN: Eighty-eight critically ill patients with multiple trauma receiving enteral nutrition will be recruited in this prospective, triple-blind, block-randomised, placebo-controlled clinical trial to receive either 0.5 g/kg/day intravenous undiluted alanyl-glutamine or intravenous placebo by continuous infusion (24 h/day). Both groups will be receiving the same standard enteral nutrition protocol and the same standard intensive care unit care. Supplementation will continue until discharge from the intensive care unit, death or a maximum duration of 3 weeks. The primary outcome will be organ-dysfunction evaluation assessed by the pattern of change in sequential organ failure assessment score over a 10-day period. The secondary outcomes are: the changes in total sequential organ failure assessment score on the last day of treatment, infectious complications during the ICU stay, 60-day mortality, length of stay in the intensive care unit and body-composition analysis. DISCUSSION: This study is the first trial to investigate the effect of intravenous alanyl-glutamine supplementation in multiple trauma patients receiving enteral nutrition on reducing severity of organ failure and infectious complications and preservation of lean body mass. TRIAL REGISTRATION NUMBER: This trial is registered at http://www.clinicaltrials.gov. NCT01240291.
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spelling pubmed-32212922011-12-01 Effect of intravenous GLutamine supplementation IN Trauma patients receiving enteral nutrition study protocol (GLINT Study): a prospective, blinded, randomised, placebo-controlled clinical trial Al Balushi, Ruqaiya M Paratz, Jennifer D Cohen, Jeremy Banks, Merrilyn Dulhunty, Joel Roberts, Jason A Lipman, Jeffrey BMJ Open Intensive Care BACKGROUND: Trauma patients are characterised by alterations in the immune system, increased exposure to infectious complications, sepsis and potentially organ failure and death. Glutamine supplementation to parenteral nutrition has been proven to be associated with improved clinical outcomes. However, glutamine supplementation in patients receiving enteral nutrition and its best route are still controversial. Previous trials have been limited by a small sample size, use of surrogate outcomes or a limited period of supplementation. The aim of this trial is to investigate if intravenous glutamine supplementation to trauma patients receiving enteral nutrition is associated with improved clinical outcomes in terms of decreased organ dysfunction, infectious complications and other secondary outcomes. METHODS/DESIGN: Eighty-eight critically ill patients with multiple trauma receiving enteral nutrition will be recruited in this prospective, triple-blind, block-randomised, placebo-controlled clinical trial to receive either 0.5 g/kg/day intravenous undiluted alanyl-glutamine or intravenous placebo by continuous infusion (24 h/day). Both groups will be receiving the same standard enteral nutrition protocol and the same standard intensive care unit care. Supplementation will continue until discharge from the intensive care unit, death or a maximum duration of 3 weeks. The primary outcome will be organ-dysfunction evaluation assessed by the pattern of change in sequential organ failure assessment score over a 10-day period. The secondary outcomes are: the changes in total sequential organ failure assessment score on the last day of treatment, infectious complications during the ICU stay, 60-day mortality, length of stay in the intensive care unit and body-composition analysis. DISCUSSION: This study is the first trial to investigate the effect of intravenous alanyl-glutamine supplementation in multiple trauma patients receiving enteral nutrition on reducing severity of organ failure and infectious complications and preservation of lean body mass. TRIAL REGISTRATION NUMBER: This trial is registered at http://www.clinicaltrials.gov. NCT01240291. BMJ Group 2011-11-14 /pmc/articles/PMC3221292/ /pubmed/22102646 http://dx.doi.org/10.1136/bmjopen-2011-000334 Text en © 2011, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.
spellingShingle Intensive Care
Al Balushi, Ruqaiya M
Paratz, Jennifer D
Cohen, Jeremy
Banks, Merrilyn
Dulhunty, Joel
Roberts, Jason A
Lipman, Jeffrey
Effect of intravenous GLutamine supplementation IN Trauma patients receiving enteral nutrition study protocol (GLINT Study): a prospective, blinded, randomised, placebo-controlled clinical trial
title Effect of intravenous GLutamine supplementation IN Trauma patients receiving enteral nutrition study protocol (GLINT Study): a prospective, blinded, randomised, placebo-controlled clinical trial
title_full Effect of intravenous GLutamine supplementation IN Trauma patients receiving enteral nutrition study protocol (GLINT Study): a prospective, blinded, randomised, placebo-controlled clinical trial
title_fullStr Effect of intravenous GLutamine supplementation IN Trauma patients receiving enteral nutrition study protocol (GLINT Study): a prospective, blinded, randomised, placebo-controlled clinical trial
title_full_unstemmed Effect of intravenous GLutamine supplementation IN Trauma patients receiving enteral nutrition study protocol (GLINT Study): a prospective, blinded, randomised, placebo-controlled clinical trial
title_short Effect of intravenous GLutamine supplementation IN Trauma patients receiving enteral nutrition study protocol (GLINT Study): a prospective, blinded, randomised, placebo-controlled clinical trial
title_sort effect of intravenous glutamine supplementation in trauma patients receiving enteral nutrition study protocol (glint study): a prospective, blinded, randomised, placebo-controlled clinical trial
topic Intensive Care
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3221292/
https://www.ncbi.nlm.nih.gov/pubmed/22102646
http://dx.doi.org/10.1136/bmjopen-2011-000334
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