Efficacy and Safety of Glutamine-supplemented Parenteral Nutrition in Surgical ICU Patients: An American Multicenter Randomized Controlled Trial
What this study found
Glutamine-supplemented PN was safe but did not improve clinical outcomes versus standard PN. Six-month mortality was 31.4% with GLN-PN and 29.7% with STD-PN (hazard ratio 1.05, 95% CI 0.58-1.88; P = 0.88), and 28-day mortality was 14.7% versus 16.0%. Hospital-acquired infections were also similar, with any infection in 52 GLN-PN events versus 39 STD-PN events and rates of 28 versus 25 per 1000 hospital days (P = 0.70). No serious adverse event was related to the study PN.
- Study & population
- This was a 1:1 randomized controlled trial at 5 US centers in 150 adult surgical ICU patients requiring parenteral nutrition after cardiac, vascular, or intestinal surgery.
- Intervention
- The active regimen was intravenous parenteral nutrition supplemented with alanyl-glutamine dipeptide at 0.5 g/kg/day, delivered as a 20% alanyl-glutamine dipeptide solution admixed into PN and continued for up to 28 days after enrollment.
- Key limitation
- The trial enrolled only 150 postoperative SICU patients, limiting power to detect modest benefits or harms.
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Open PDFOriginal abstract
Objective:To determine whether glutamine (GLN)-supplemented parenteral nutrition (PN) improves clinical outcomes in surgical intensive care unit (SICU) patients. Summary Background Data:GLN requirements may increase with critical illness. GLN-supplemented PN may improve clinical outcomes in SICU patients. Methods:A parallel-group, multicenter, double-blind, randomized, controlled clinical trial in 150 adults after gastrointestinal, vascular, or cardiac surgery requiring PN and SICU care. Patients were without significant renal or hepatic failure or shock at entry. All received isonitrogenous, isocaloric PN [1.5 g/kg/d amino acids (AAs) and energy at 1.3× estimated basal energy expenditure]. Controls (n = 75) received standard GLN-free PN (STD-PN); the GLN group (n = 75) received PN containing alanyl-GLN dipeptide (0.5 g/kg/d), proportionally replacing AA in PN (GLN-PN). Enteral nutrition (EN) was advanced and PN weaned as indicated. Hospital mortality and infections were primary endpoints. Results:Baseline characteristics, days on study PN and daily macronutrient intakes via PN and EN, were similar between groups. There were 11 hospital deaths (14.7%) in the GLN-PN group and 13 deaths in the STD-PN group (17.3%; difference, −2.6%; 95% confidence interval, −14.6% to 9.3%; P = 0.66). The 6-month cumulative mortality was 31.4% in the GLN-PN group and 29.7% in the STD-PN group (P = 0.88). Incident bloodstream infection rate was 9.6 and 8.4 per 1000 hospital days in the GLN-PN and STD-PN groups, respectively (P = 0.73). Other clinical outcomes and adverse events were similar. Conclusions:PN supplemented with GLN dipeptide was safe, but did not alter clinical outcomes among SICU patients.