Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients

Phase 3

Completed

• Conditions: Critical Illness; Enteral Nutrition; Multiple Organ Failure; Infection Complication; Inflammation
• Interventions: Drug: Glutamin; Other: Maltodextrin

• Registration Number: NCT02998931
• Lead Sponsor: Shahid Beheshti University

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.

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 Timeline

• Study Start: 2016-11-10
• Study First Submitted: 2016-12-14
• Study First Submitted QC: 2016-12-16
• Study First Posted: 2016-12-21
• Primary Completion: 2018-08-25
• Study Completion: 2018-09-10
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-13
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glutamin	Glutamin	Intervention patients will be received enteral formula and glutamine 0.3 g/kg/day given via nasogastric tube as boluses q 4hrs.
maltodextrin	Maltodextrin	Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.

Primary Outcome Measures

Name	Time	Method
Occurrence of infection	Day 28	Incidence of infections

Secondary Outcome Measures

Name	Time	Method
Serum Immunity Markers	baseline, Day 5, Day 10
Length of stay in ICU	Day 28
Serum Inflammatory Markers	baseline, Day 5, Day 10	Inflammatory factors
28-day Mortality	Day 28	Day 28
6-month mortality	month 6	month 6

Trial Locations

Locations (2)

Shohada Tajrish Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of

Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of