Trial of Enteral Glutamine on Intestinal Permeability in Critically Ill Patients

Shahid Beheshti University60 enrolled

Overview

Glutamine-induced recovery in intestinal barrier function by reducing bacterial translocation was demonstrated in previous studies. In this trial, intensive care unit patients with enteral feeding will receive either enteral glutamine or maltodextrin as placebo for 10 days and the effects of the intervention on intestinal permeability will be assessed.

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 60 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 10days and control patients will be received maltodextrin along with enteral formula for 10 days. Patients will be evaluated for plasma endotoxin and plasma zonulin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Critical Illness Enteral Nutrition Intestinal Permeability

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 * 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 (1)

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

Tehran, Iran

Outcomes

Primary Outcomes

Maximum plasma endotoxin concentration

The levels of plasma endotoxin

Time frame: baseline, Day 5, Day 10

Maximum plasma zonulin concentration

The levels of plasma zonulin

Time frame: baseline, Day 5, Day 10

Maximum plasma antiendotoxin IgG and Ig M concentration

The levels of plasma antiendotoxin IgG and Ig M concentration

Time frame: baseline, Day 5, Day 10

Secondary Outcomes

Gastrointestinal complication

abdominal distention, vomiting, diarrhea and constipation

Time frame: Day10

Mortality in ICU

Mortality rate in ICU

Time frame: Day 10

Length of stay in ICU

Duration of stay in ICU

Time frame: Day 10

Severe sepsis

according to the American College of Chest Physicians and the Society of Critical Care Medicine

Time frame: Day 10

Data from ClinicalTrials.gov

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