Iranian Intensive Care Unit (ICU) Glutamine Study

N/ACompletedNCT01219608

Shahid Beheshti University of Medical Sciences60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Trauma Patients in ICU

Interventions

Glutamine 0.5 g/kg/dayDIETARY_SUPPLEMENT

Glutamine 0.5 g/kg/day

Glutamine 1 g/kg/dayDIETARY_SUPPLEMENT

Glutamine 1 g/kg/day

Enteral NutritionDIETARY_SUPPLEMENT

Ordinary Enteral Nutrition

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Al-Zahra Hospital

Isfahan, Isfahan, Iran

Outcomes

Primary Outcomes

Infection Probability Score

Infection Probability Score will be measured and will be compared to the baseline after 10 days of the intervention

Time frame: 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

Time frame: 10 days after intervention

Secondary Outcomes

Prealbumin

Prealbumin will be measured and will be compared to the baseline after 10 days of the intervention

Time frame: 10 days after intervention

CRP

CRP will be measured and will be compared to the baseline after 10 days of the intervention

Time frame: 10 days after intervention

Serum prealbumin

Prealbumin will be measured and will be compared to the baseline after 10 days of the intervention

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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