A Randomized Trial of Enteral Glutamine for Treatment of Burn Injuries.
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
15 09 2022
15 09 2022
Historique:
pubmed:
10
9
2022
medline:
17
9
2022
entrez:
9
9
2022
Statut:
ppublish
Résumé
Glutamine is thought to have beneficial effects on the metabolic and stress response to severe injury. Clinical trials involving patients with burns and other critically ill patients have shown conflicting results regarding the benefits and risks of glutamine supplementation. In a double-blind, randomized, placebo-controlled trial, we assigned patients with deep second- or third-degree burns (affecting ≥10% to ≥20% of total body-surface area, depending on age) within 72 hours after hospital admission to receive 0.5 g per kilogram of body weight per day of enterally delivered glutamine or placebo. Trial agents were given every 4 hours through a feeding tube or three or four times a day by mouth until 7 days after the last skin grafting procedure, discharge from the acute care unit, or 3 months after admission, whichever came first. The primary outcome was the time to discharge alive from the hospital, with data censored at 90 days. We calculated subdistribution hazard ratios for discharge alive, which took into account death as a competing risk. A total of 1209 patients with severe burns (mean burn size, 33% of total body-surface area) underwent randomization, and 1200 were included in the analysis (596 patients in the glutamine group and 604 in the placebo group). The median time to discharge alive from the hospital was 40 days (interquartile range, 24 to 87) in the glutamine group and 38 days (interquartile range, 22 to 75) in the placebo group (subdistribution hazard ratio for discharge alive, 0.91; 95% confidence interval [CI], 0.80 to 1.04; P = 0.17). Mortality at 6 months was 17.2% in the glutamine group and 16.2% in the placebo group (hazard ratio for death, 1.06; 95% CI, 0.80 to 1.41). No substantial between-group differences in serious adverse events were observed. In patients with severe burns, supplemental glutamine did not reduce the time to discharge alive from the hospital. (Funded by the U.S. Department of Defense and the Canadian Institutes of Health Research; RE-ENERGIZE ClinicalTrials.gov number, NCT00985205.).
Sections du résumé
BACKGROUND
Glutamine is thought to have beneficial effects on the metabolic and stress response to severe injury. Clinical trials involving patients with burns and other critically ill patients have shown conflicting results regarding the benefits and risks of glutamine supplementation.
METHODS
In a double-blind, randomized, placebo-controlled trial, we assigned patients with deep second- or third-degree burns (affecting ≥10% to ≥20% of total body-surface area, depending on age) within 72 hours after hospital admission to receive 0.5 g per kilogram of body weight per day of enterally delivered glutamine or placebo. Trial agents were given every 4 hours through a feeding tube or three or four times a day by mouth until 7 days after the last skin grafting procedure, discharge from the acute care unit, or 3 months after admission, whichever came first. The primary outcome was the time to discharge alive from the hospital, with data censored at 90 days. We calculated subdistribution hazard ratios for discharge alive, which took into account death as a competing risk.
RESULTS
A total of 1209 patients with severe burns (mean burn size, 33% of total body-surface area) underwent randomization, and 1200 were included in the analysis (596 patients in the glutamine group and 604 in the placebo group). The median time to discharge alive from the hospital was 40 days (interquartile range, 24 to 87) in the glutamine group and 38 days (interquartile range, 22 to 75) in the placebo group (subdistribution hazard ratio for discharge alive, 0.91; 95% confidence interval [CI], 0.80 to 1.04; P = 0.17). Mortality at 6 months was 17.2% in the glutamine group and 16.2% in the placebo group (hazard ratio for death, 1.06; 95% CI, 0.80 to 1.41). No substantial between-group differences in serious adverse events were observed.
CONCLUSIONS
In patients with severe burns, supplemental glutamine did not reduce the time to discharge alive from the hospital. (Funded by the U.S. Department of Defense and the Canadian Institutes of Health Research; RE-ENERGIZE ClinicalTrials.gov number, NCT00985205.).
Identifiants
pubmed: 36082909
doi: 10.1056/NEJMoa2203364
doi:
Substances chimiques
Glutamine
0RH81L854J
Banques de données
ClinicalTrials.gov
['NCT00985205']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1001-1010Subventions
Organisme : U.S. Department of Defense
ID : W81XWH-09-2-0194
Organisme : CIHR
ID : 137117
Pays : Canada
Organisme : CIHR
ID : 142388
Pays : Canada
Organisme : CIHR
ID : 137117
Pays : Canada
Organisme : CIHR
ID : 142388
Pays : Canada
Investigateurs
Lucy Wibbenmeyer
(L)
Judith Pena-Quevedo
(J)
Alba Aguillon
(A)
Claire Johnson
(C)
Colette Galet
(C)
Jonathan Pollack
(J)
John Shuman
(J)
Teresa Beaudoin
(T)
Elizabeth Shannon
(E)
Joseph M Still
(JM)
Bruce Friedman
(B)
Pat Samonsky
(P)
Joan Wilson
(J)
Austin Price
(A)
Alexis Turgeon
(A)
David Bellemarre
(D)
Eve Cloutier
(E)
Niknam Eshraghi
(N)
Kristin Hickey
(K)
Paul Fitzpatrick
(P)
Marc Jeschke
(M)
Sarah Rehou
(S)
Diana Tedesco
(D)
Arek Wiktor
(A)
Tyler Smith
(T)
Tracey MacDermott
(T)
Sylvain Belisle
(S)
Ali Ghamraoui
(A)
Martine Lebrasseur
(M)
Fatna Benettaib
(F)
Dounia Boumahni
(D)
Daisy Grau
(D)
Alicia Baez
(A)
Carmen Baez
(C)
Sam Mandell
(S)
Emily Eschelbach
(E)
Austin Bailey
(A)
Dari Zapata
(D)
Sai R Velamuri
(SR)
Yvonne Shaw
(Y)
David Hill
(D)
Gabriel Hundeshagen
(G)
Ann Kechler
(A)
David Smith
(D)
Thanh Tran
(T)
Michelle Jung
(M)
Beth Montera
(B)
Naiem Moiemen
(N)
Liesl Despy
(L)
Ariel Abally
(A)
Ben Kelly
(B)
Frances Philp
(F)
Kayvan Shokrollahi
(K)
Liby Philip
(L)
Kevin Foster
(K)
Claudia Islas
(C)
Fredrik Huss
(F)
Marie Lindblad
(M)
Declan Collins
(D)
Laura Martins
(L)
Alisa Savetamal
(A)
Joyce Wall
(J)
Melissa Ebdon
(M)
Jennifer Gurney
(J)
Amanda Wagner
(A)
Nicholas Meyer
(N)
Margaret Wilson
(M)
Nadia Depetris
(N)
Elisa Cortes
(E)
Christian Stoppe
(C)
Aileen Hill
(A)
Sylvia Bromler
(S)
Jeffrey Shupp
(J)
Sarah Burkey
(S)
Preetha Muthayya
(P)
Sarah Buckley
(S)
Arianna Dal Cin
(A)
Natalie Hanna
(N)
Carrie Johnston
(C)
John Crow
(J)
Danielle Rogers
(D)
Joann Katz
(J)
Jessica Kracker
(J)
Heather Belacic
(H)
Kirsten Colpaert
(K)
Jolien Van Heck
(J)
James Holmes
(J)
Carmen Sabio
(C)
Anne-Françoise Rousseau
(AF)
Marjorie Fadeur
(M)
Edward Tredget
(E)
Tom Stelfox
(T)
Cassidy Codan
(C)
Olesya Dmitrieva
(O)
Jon Wisler
(J)
Adara McCarty
(A)
Tina Palmieri
(T)
Katrina Falwell
(K)
Kareem Abdelfattah
(K)
Kathryn Naumann
(K)
David-Benjamin Lumenta
(DB)
Birgit Michelitsch
(B)
Pattama Punyavong
(P)
Chanasda Sopharak
(C)
Carmen Vivó
(C)
Diana Vicente Miralles
(DV)
Warren Garner
(W)
Haig Yenikomshian
(H)
Janet Luong
(J)
Charles Wade
(C)
Garrett Jost
(G)
Ian Clement
(I)
Maite Babio-Galan
(M)
Pornprom Muangman
(P)
Kusuma Chinaroonchai
(K)
Tanut Sornmanapong
(T)
Waree Hanpisut
(W)
João Manoel Silva
(JM)
Veruska Scabim
(V)
Lyndsay Deeter
(L)
Bonnie Feilmeier
(B)
David Mozingo
(D)
Ian Driscoll
(I)
Tera Thigpin
(T)
David Voigt
(D)
Mike Miriovsky
(M)
Apichai Angspatt
(A)
Jiraporn Prompila
(J)
Gek Kim Sharon Ong
(GKS)
Fenfen Wang
(F)
Andrew Bright
(A)
Kate Ledbetter
(K)
Samantha McNally
(S)
Joanne Bradley-Potts
(J)
Jessica Summers
(J)
Karen Taylor
(K)
Victoria Soñé
(V)
Kisbel Peña
(K)
Cristina Marmolejos
(C)
David Herndon
(D)
Evan Ross
(E)
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