Iranian Intensive Care Unit (ICU) Glutamine Study

Study Overview
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Brief Summary
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This is a double-blinded placebo-controlled block randomized study in intensive care patients comparing enteral glutamine supplementation to placebo. The hypothesis is an improvement of clinical and paraclinical outcomes. The primary endpoint is Infection Probability Score (IPS) and Systemic Inflammatory Response Syndrome (SIRS). Anthropometric measures and serum inflammatory mediators will be compared.

Official Title
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Iranian Intensive Care Unit (ICU) Glutamine Study

Conditions
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Trauma Patients in ICU

Intervention / Treatment
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* Dietary Supplement: Glutamine 0.5 g/kg/day
* Dietary Supplement: Glutamine 1 g/kg/day
* Dietary Supplement: Enteral Nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-60 No corticosteroids use No history of heart, liver and kidney diseases Nutrition through nasogastric or orogastric Exclusion Criteria: Patients who will not tolerate enteral nutrition for more than 48 hours Patients who are NPO and nutritional support has not started Lactating and pregnant women Kidney failure during the study A history of glutamin supplement use before the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glutamine 0.5 g/kg/day<br> | Dietary Supplement: Glutamine 0.5 g/kg/day<br>* Glutamine 0.5 g/kg/day<br>|
| Active Comparator: Glutamine 1 g/kg/day<br> | Dietary Supplement: Glutamine 1 g/kg/day<br>* Glutamine 1 g/kg/day<br>|
| Placebo Comparator: Enteral Nutrition<br> | Dietary Supplement: Enteral Nutrition<br>* Ordinary Enteral Nutrition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection Probability Score | Infection Probability Score will be measured and will be compared to the baseline after 10 days of the intervention | 10 days after intervention | 
| Systemic Inflammatory Response Syndrome | Systemic Inflammatory Response Syndrome will be measured and will be compared to the baseline after 10 days of the intervention | 10 days after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prealbumin | Prealbumin will be measured and will be compared to the baseline after 10 days of the intervention | 10 days after intervention | 
| CRP | CRP will be measured and will be compared to the baseline after 10 days of the intervention | 10 days after intervention | 
| Serum prealbumin | Prealbumin will be measured and will be compared to the baseline after 10 days of the intervention | 10 days after the intervention | 
| Length of stay (LOS) | LOS will be measured and will be compared to the baseline after 10 days of the intervention |  | 
| Bed sores | Bed sores will be measured and will be compared to the baseline after 10 days of the intervention | 10 days after intervention | 
| Mechanical ventilation | Mean mechanical ventilation need will be measured and will be compared to the baseline after 10 days of the intervention | 10 days after intervention |