Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients

Study Overview
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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.

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.

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

Conditions
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Critical Illness, Enteral Nutrition, Multiple Organ Failure, Infection Complication, Inflammation

Intervention / Treatment
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* Drug: Glutamin
* Other: Maltodextrin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glutamin<br>Intervention patients will be received enteral formula and glutamine 0.3 g/kg/day given via nasogastric tube as boluses q 4hrs. | Drug: Glutamin<br>* Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs<br>* Other names: L-glutamine;|
| Placebo Comparator: maltodextrin<br>Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs. | Other: Maltodextrin<br>* Maltodextrin mixed with water given via NG tube Q 4 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of infection | Incidence of infections | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Inflammatory Markers | Inflammatory factors | baseline, Day 5, Day 10 | 
| Serum Immunity Markers |  | baseline, Day 5, Day 10 | 
| Length of stay in ICU |  | Day 28 | 
| 28-day Mortality | Day 28 | Day 28 | 
| 6-month mortality | month 6 | month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glutamin, Enteral Nutrition, Intensive Care Unit, Critical Care Outcomes, inflammatory, Immune System