Iranian Intensive Care Unit (ICU) Glutamine Study

Not Applicable

Completed

• Conditions: Trauma Patients in ICU
• Interventions: Dietary Supplement: Glutamine 0.5 g/kg/day; Dietary Supplement: Glutamine 1 g/kg/day; Dietary Supplement: Enteral Nutrition

• Registration Number: NCT01219608
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Status Verified: 2010-10
• Study First Submitted: 2010-10-06
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-13
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-13
• Last Update Posted: 2011-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Glutamine 0.5 g/kg/day	Glutamine 0.5 g/kg/day	-
Glutamine 1 g/kg/day	Glutamine 1 g/kg/day	-
Enteral Nutrition	Enteral Nutrition	-

Primary Outcome Measures

Name	Time	Method
Infection Probability Score	10 days after intervention	Infection Probability Score will be measured and will be compared to the baseline after 10 days of the intervention
Systemic Inflammatory Response Syndrome	10 days after intervention	Systemic Inflammatory Response Syndrome will be measured and will be compared to the baseline after 10 days of the intervention

Secondary Outcome Measures

Name	Time	Method
Bed sores	10 days after intervention	Bed sores will be measured and will be compared to the baseline after 10 days of the intervention
Prealbumin	10 days after intervention	Prealbumin will be measured and will be compared to the baseline after 10 days of the intervention
CRP	10 days after intervention	CRP will be measured and will be compared to the baseline after 10 days of the intervention
Serum prealbumin	10 days after the intervention	Prealbumin will be measured and will be compared to the baseline after 10 days of the intervention
Length of stay (LOS)		LOS will be measured and will be compared to the baseline after 10 days of the intervention
Mechanical ventilation	10 days after intervention	Mean mechanical ventilation need will be measured and will be compared to the baseline after 10 days of the intervention

Trial Locations

Locations (1)

Al-Zahra Hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of