TY - JOUR
T1 - A Randomized Trial of Enteral Glutamine for Treatment of Burn Injuries
AU - RE-ENERGIZE Trial Team
AU - Heyland, Daren K.
AU - Wibbenmeyer, Lucy
AU - Pollack, Jonathan A.
AU - Friedman, Bruce
AU - Turgeon, Alexis F.
AU - Eshraghi, Niknam
AU - Jeschke, Marc G.
AU - Belisle, Sylvain
AU - Grau, Daisy
AU - Mandell, Samuel
AU - Velamuri, Sai R.
AU - Hundeshagen, Gabriel
AU - Moiemen, Naiem
AU - Shokrollahi, Kayvan
AU - Foster, Kevin
AU - Huss, Fredrik
AU - Collins, Declan
AU - Savetamal, Alisa
AU - Gurney, Jennifer M.
AU - Depetris, Nadia
AU - Stoppe, Christian
AU - Ortiz-Reyes, Luis
AU - Garrel, Dominique
AU - Day, Andrew G.
N1 - Funding Information:
Supported by the U.S. Department of Defense (award number, W81XWH-09-2-0194 for the pilot phase) and the Canadian Institutes of Health Research (funding reference numbers, MCT-94834 for the pilot phase and 14238 for the definitive phase).
Publisher Copyright:
Copyright © 2022 Massachusetts Medical Society.
PY - 2022/9/15
Y1 - 2022/9/15
N2 - 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 bodysurface 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.
AB - 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 bodysurface 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.
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U2 - 10.1056/NEJMoa2203364
DO - 10.1056/NEJMoa2203364
M3 - Article
C2 - 36082909
AN - SCOPUS:85138444747
SN - 0028-4793
VL - 387
SP - 1001
EP - 1010
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 11
ER -