Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients

Shahid Beheshti University200 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

200

Conditions

Critical Illness Enteral Nutrition Multiple Organ Failure Infection Complication Inflammation

Interventions

GlutaminDRUG

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

MaltodextrinOTHER

Maltodextrin mixed with water given via NG tube Q 4 hours

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences

Tehran, Iran

Shohada Tajrish Hospital

Tehran, Iran

Outcomes

Primary Outcomes

Occurrence of infection

Incidence of infections

Time frame: Day 28

Secondary Outcomes

Serum Inflammatory Markers

Inflammatory factors

Time frame: baseline, Day 5, Day 10

Serum Immunity Markers

Time frame: baseline, Day 5, Day 10

Length of stay in ICU

Time frame: Day 28

28-day Mortality

Day 28

Time frame: Day 28

6-month mortality

month 6

Time frame: month 6

Data from ClinicalTrials.gov

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