Efficacy and Safety of Glutamine-supplemented Parenteral Nutrition in Surgical ICU Patients: An American Multicenter Randomized Controlled Trial

• Type of Material: Article
• Authors: Thomas Ziegler, Emory University; Addison K. May, Vanderbilt University; Gautam Hebbar, Emory University; Kirk Easley, Emory University; Daniel P. Griffith, Emory University; Nisha Dave, Emory University; Bryan R. Collier, Vanderbilt University; George Cotsonis, Emory University; Li Hao, Emory University; Traci Leong, Emory University; Amita Manatunga, Emory University; Eli Rosenberg, Emory University; Dean Jones, Emory University; Gregory Martin, Emory University; Gordon L. Jensen, Pennsylvania State University; Harry C. Sax, Miriam Hospital; Kenneth A. Kudsk, University of Wisconsin; John Galloway, Emory University; Henry Blumberg, Emory University; Mary E. Evans, National Institute of Diabetes and Digestive and Kidney Diseases; Paul E. Wischmeyer, University of Colorado
• Language: English
• Date: 2016-04-01
• Publisher: Lippincott, Williams & Wilkins
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2015 Wolters Kluwer Health, Inc. All rights reserved.
• Final Published Version (URL): http://dx.doi.org/10.1097/SLA.0000000000001487
• Title of Journal or Parent Work: Annals of Surgery
• ISSN: 0003-4932
• Volume: 263
• Issue: 4
• Start Page: 646
• End Page: 655
• Grant/Funding Information: This work was supported, in part, by National Institutes of Health grants U01 DK069322 and K24 DK096574 (TRZ), UL1 TR000454 (Atlanta Clinical and Translational Science Institute), K23 RR018379 and R01 GM078312 (PEW) and an investigator-initiated grant from Fresenius Kabi (TRZ).
• Keywords: DOUBLE-BLIND; glutamine; critical illness; critical care; INTENSIVE-CARE-UNIT; nutrition support; CLINICAL-TRIAL; parenteral nutrition; Life Sciences & Biomedicine; hospital-acquired infection; Surgery
• Research Categories: Health Sciences, Nutrition; Health Sciences, Medicine and Surgery

Abstract

Objective: To determine whether glutamine (GLN)-supplemented parenteral nutrition (PN) improves clinical outcomes in surgical ICU (SICU) patients. Summary Background Data: GLN requirements may increase with critical illness. GLN-supplemented PN may improve clinical outcomes in SICU patients, but data in patient subgroups are limited. Methods: A parallel-group, multicenter, double blind, randomized, controlled clinical trial in adults after gastrointestinal, vascular, or cardiac surgery who required PN and SICU care. Subjects were without significant renal or hepatic failure or shock at entry. All received isonitrogenous, isocaloric PN [1.5 g/kg/d amino acids (AA) 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 control 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 energy and amino acid/protein 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 and (17.3%; difference, −2.6%; 95% confidence interval −14.6 to 9.3%; P = 0.66). The 6-month cumulative all-cause 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.