Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients

Inflammation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02998931
• Other study ID #: 1395/670
• Status: Completed
• Phase: Phase 3
• Start date: November 10, 2016
• Est. completion date: September 10, 2018

Study information

• Verified date: October 2018
• Source: Shahid Beheshti University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 10, 2018
• Est. primary completion date: August 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Enteral Nutrition
• Infection Complication
• Inflammation
• Multiple Organ Failure

Intervention

Drug:
• Glutamin
Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs

Other:
• Maltodextrin
Maltodextrin mixed with water given via NG tube Q 4 hours

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (6)

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. — View Citation

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.. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum Glutamin		baseline, Day 5, Day 10
Primary	Occurrence of infection	Incidence of infections	Day 28
Secondary	Serum Inflammatory Markers	Inflammatory factors	baseline, Day 5, Day 10
Secondary	Serum Immunity Markers		baseline, Day 5, Day 10
Secondary	Length of stay in ICU		Day 28
Secondary	28-day Mortality	Day 28	Day 28
Secondary	6-month mortality	month 6	month 6