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Consequences of the REDOXS and METAPLUS Trials
Author(s) -
Zanten Arthur R. H.,
Hofman Zandrie,
Heyland Daren K.
Publication year - 2015
Publication title -
journal of parenteral and enteral nutrition
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.935
H-Index - 98
eISSN - 1941-2444
pISSN - 0148-6071
DOI - 10.1177/0148607114567201
Subject(s) - medicine , intensive care unit , general hospital , library science , pediatrics , intensive care medicine , computer science
The REDOXS Trial was a factorial 2x2 randomized trial conducted in 40 intensive care units (ICUs) in North America and Europe. A total of 1223 mechanically ventilated adult patients with multi-organ failure were randomized to receive glutamine, antioxidants, both, or placebo. Consistent with a pharmaconutrition approach, patients received high doses of study nutrients administered separate from artificial nutrition (intravenous glutamine supplementation [0.35 g/kg/day parenterally provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine,and an additional 30 g/day of glutamine enterally, provided as 42.5 g alanylglutamine and glycine-glutamine dipeptides). Contrary to the study hypothesis, the primary analysis demonstrated no clinical benefit of these nutritional interventions and identified a trend toward increased mortality at 28 days (32.4% vs. 27.2%; adjusted odds ratio, 1.28; 95% confidence interval [CI], 1.00 to 1.64; P = 0.049) and a significant increase in hospital and 6 month mortality among patients who received glutamine as compared with those who did not receive glutamine. Overall, there was no effect of antioxidants on 28-day mortality (30.8%, vs. 28.8%; adjusted odds ratio, 1.09; 95% CI, 0.86 to 1.40; P = 0.48). In a post hoc subgroup analysis, both glutamine and antioxidants appeared most harmful in patients with baseline renal dysfunction. No subgroups suggested reduced mortality with supplements. The adverse effects of glutamine observed in the REDOXS trial were partially attributed to the high dose of study supplements provided to these patients.