NCT02998931

Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients

Effects of Enteral Glutamine on Inflammatory Response, Immune System Function and Clinical Outcomes in Hospitalized Patients With Enteral Feeding in Intensive Care Unit

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Shahid Beheshti University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-11-10
• Primary completion: 2018-08-25
• Completion: 2018-09-10
• First posted: 2016-12-21
• Last updated: 2018-10-16

Locations

2 sites across 1 country: Iran