Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT02998931

Recruitment Status : Completed

First Posted : December 21, 2016

Last Update Posted : October 16, 2018

Sponsor:

Information provided by (Responsible Party):

Zahra Vahdat Shariatpanahi, Shahid Beheshti University

Study Description

Brief Summary:

Glutamine supplementation has beneficial effects on morbidity and mortality in critically ill patients, possibly in part through an attenuation of the proinflammatory cytokine response and a Immune function. In this trial intensive care unit patients with enteral feeding will receive either enteral glutamine or maltodextrin as placebo for 28 days.

Condition or disease	Intervention/treatment	Phase
Critical Illness Enteral Nutrition Multiple Organ Failure Infection Complication Inflammation	Drug: Glutamin Other: Maltodextrin	Phase 3

Detailed Description:

A randomized, double blind, controlled trial will be conducted in general intensive care unit (ICU) in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. The participants are 200 eligible hospitalized patients with enteral feeding in ICU, aged ≥ 18 years. Intervention patients will be received 0.3 g/kg/day of glutamine along with enteral formula for 28 days and control patients will be received maltodextrin along with enteral formula for 28 days. Patients will be evaluated for occurrence of new infection, organ failure, duration of stay in ICU, 28 days and 6 months mortality and inflammatory and immune markers.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Effects of Enteral Glutamine on Inflammatory Response, Immune System Function and Clinical Outcomes in Hospitalized Patients With Enteral Feeding in Intensive Care Unit
Actual Study Start Date :	November 10, 2016
Actual Primary Completion Date :	August 25, 2018
Actual Study Completion Date :	September 10, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Glutamin Intervention patients will be received enteral formula and glutamine 0.3 g/kg/day given via nasogastric tube as boluses q 4hrs.	Drug: Glutamin Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs Other Name: L-glutamine
Placebo Comparator: maltodextrin Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.	Other: Maltodextrin Maltodextrin mixed with water given via NG tube Q 4 hours

Outcome Measures

Primary Outcome Measures :

Occurrence of infection [ Time Frame: Day 28 ]
Incidence of infections

Secondary Outcome Measures :

Serum Inflammatory Markers [ Time Frame: baseline, Day 5, Day 10 ]
Inflammatory factors
Serum Immunity Markers [ Time Frame: baseline, Day 5, Day 10 ]
Length of stay in ICU [ Time Frame: Day 28 ]
28-day Mortality [ Time Frame: Day 28 ]
Day 28
6-month mortality [ Time Frame: month 6 ]
month 6

Other Outcome Measures:

Serum Glutamin [ Time Frame: baseline, Day 5, Day 10 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult patients (>18 years old) admitted to ICU
Start of study intervention within 48 hours after ICU admission
Expected to require enteral nutrition for at least 72 hours aiming for full enteral nutrition and receive at least 80 percent of enteral formula during the first 48 hour
Written informed consent of patient or written informed consent of legal representative

Exclusion Criteria:

Enrollment in a related ICU interventional study
Requiring other specific enteral nutrition for medical reason
Death or Discharge before 5th day
Having any contra-indication to receive enteral nutrition
Pregnant patients or lactating with the intent to breastfeed
Requiring other specific enteral nutrition for medical reason
BMI <18 or > 40.0 kg/m2
Have life expectancy of <6 mo
Patients who are moribond
Liver cirrhosis- Child's class C liver disease
Have seizure disorder requiring anticonvulsant
History of allergy or intolerance to the study product components
Receiving glutamine during two weeks before start study product
Have other reasons

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998931

Locations

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Iran, Islamic Republic of
Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences
Tehran, Iran, Islamic Republic of
Shohada Tajrish Hospital
Tehran, Iran, Islamic Republic of

Sponsors and Collaborators

Shahid Beheshti University

Investigators

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Study Chair:	Zahra Vahdat Shariatpanahi, MD, PhD	Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran

More Information

Publications:

van Zanten AR, Sztark F, Kaisers UX, Zielmann S, Felbinger TW, Sablotzki AR, De Waele JJ, Timsit JF, Honing ML, Keh D, Vincent JL, Zazzo JF, Fijn HB, Petit L, Preiser JC, van Horssen PJ, Hofman Z. High-protein enteral nutrition enriched with immune-modulating nutrients vs standard high-protein enteral nutrition and nosocomial infections in the ICU: a randomized clinical trial. JAMA. 2014 Aug 6;312(5):514-24. doi: 10.1001/jama.2014.7698.

Heyland D, Muscedere J, Wischmeyer PE, Cook D, Jones G, Albert M, Elke G, Berger MM, Day AG; Canadian Critical Care Trials Group. A randomized trial of glutamine and antioxidants in critically ill patients. N Engl J Med. 2013 Apr 18;368(16):1489-97. doi: 10.1056/NEJMoa1212722. Erratum in: N Engl J Med. 2013 May 9;368(19):1853. Dosage error in article text..

McClave SA, Taylor BE, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C; Society of Critical Care Medicine; American Society for Parenteral and Enteral Nutrition. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2016 Feb;40(2):159-211. doi: 10.1177/0148607115621863. Erratum in: JPEN J Parenter Enteral Nutr. 2016 Nov;40(8):1200.

Kreymann KG, Berger MM, Deutz NE, Hiesmayr M, Jolliet P, Kazandjiev G, Nitenberg G, van den Berghe G, Wernerman J; DGEM (German Society for Nutritional Medicine), Ebner C, Hartl W, Heymann C, Spies C; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Intensive care. Clin Nutr. 2006 Apr;25(2):210-23. Epub 2006 May 11.

McQuiggan M, Kozar R, Sailors RM, Ahn C, McKinley B, Moore F. Enteral glutamine during active shock resuscitation is safe and enhances tolerance of enteral feeding. JPEN J Parenter Enteral Nutr. 2008 Jan-Feb;32(1):28-35.

Hall JC, Dobb G, Hall J, de Sousa R, Brennan L, McCauley R. A prospective randomized trial of enteral glutamine in critical illness. Intensive Care Med. 2003 Oct;29(10):1710-6. Epub 2003 Aug 16.

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Responsible Party:	Zahra Vahdat Shariatpanahi, Associate Professor, Shahid Beheshti University
ClinicalTrials.gov Identifier:	NCT02998931
Other Study ID Numbers:	1395/670
First Posted:	December 21, 2016 Key Record Dates
Last Update Posted:	October 16, 2018
Last Verified:	October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Zahra Vahdat Shariatpanahi, Shahid Beheshti University:


Glutamin Enteral Nutrition Intensive Care Unit	Critical Care Outcomes inflammatory Immune System

Additional relevant MeSH terms:

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Inflammation Critical Illness Multiple Organ Failure	Pathologic Processes Disease Attributes Shock

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