Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-10

Study Completion Date

2018-09-10

Brief Summary

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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.

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Detailed Description

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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

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Critical Illness Enteral Nutrition Multiple Organ Failure Infection Complication Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Glutamin

Intervention patients will be received enteral formula and glutamine 0.3 g/kg/day given via nasogastric tube as boluses q 4hrs.

Group Type EXPERIMENTAL

Glutamin

Intervention Type DRUG

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

maltodextrin

Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type OTHER

Maltodextrin mixed with water given via NG tube Q 4 hours

Interventions

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Glutamin

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

Intervention Type DRUG

Maltodextrin

Maltodextrin mixed with water given via NG tube Q 4 hours

Intervention Type OTHER

Other Intervention Names

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L-glutamine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No