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Author Notes:

To whom correspondence should be addressed: Thomas R. Ziegler, Atlanta Clinical and Translational Science Institute, Suite GG-23, Emory University Hospital, 1364 Clifton Rd., Atlanta, GA 30322. Phone: (404) 727-7351 Fax: (404) 727-5563 ; Email: tzieg01@emory.edu.

The authors acknowledge the diligent efforts of the site study coordinators Judy Jenkins, R.N., MSN. and Vanessa Kumpf, Pharm.D. (Vanderbilt University), Elizabeth Luzier, R.N., P.R.A., (University of Colorado), Michelle Gaudreau, R.N., B.S.N., (Miriam Hospital), Debora Gawin, R.N. (university of Wisconsin), the site SICU nurses and staff and the site hospital nutrition support team members for their performance of the study and care of the subjects. We gratefully acknowledge the Data and Safety Monitoring Board members, Stephen A. McClave, M.D. (Chair), Bruce R. Bistrian M.D., Ph.D., Khursheed Jeejeebhoy, M.B.B.S., Ph.D., Fredrick A. Moore, M.D., and Feng Gao, Ph.D. for their guidance, helpful suggestions, serial data interpretation, and careful efforts in monitoring trial progress. We thank Emory DCC staff for data monitoring, management and analysis, Seegar Swanson, B.S., Lu Lu, M.S., Nana Freret, R.N., M.S.N, Thandeka Tutu-Gxashe, M.P.H., and Baohua Wu, M.S. Special thanks to Carolyn Miles, PhD, from the National Institutes of Health (NIH)/NIDDK for her support and helpful advice throughout the study; Suzanne S. Gebhart, M.D., of Emory University for serving as the Medical Safety Monitor; and Ewald Schlotzer, PhD, from Fresenius-Kabi for provision of the study GLN dipeptide and ancillary research support.

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Research Funding:

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:

  • Life Sciences & Biomedicine
  • Surgery
  • critical care
  • critical illness
  • glutamine
  • hospital-acquired infection
  • nutrition support
  • parenteral nutrition
  • INTENSIVE-CARE-UNIT
  • DOUBLE-BLIND
  • CLINICAL-TRIAL

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

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Journal Title:

Annals of Surgery

Volume:

Volume 263, Number 4

Publisher:

, Pages 646-655

Type of Work:

Article | Post-print: After Peer Review

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.

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