Iranian Intensive Care Unit (ICU) Glutamine Study

Shahid Beheshti University of Medical Sciences

Status: Completed

Conditions: Trauma Patients in ICU

Treatments: Dietary Supplement: Enteral Nutrition; Dietary Supplement: Glutamine 1 g/kg/day; Dietary Supplement: Glutamine 0.5 g/kg/day

Study type: Interventional

Funder types: Other

Identifiers

NCT01219608

eums1388

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

Glutamine 0.5 g/kg/day

Active Comparator group

Treatment:

Dietary Supplement: Glutamine 0.5 g/kg/day

Glutamine 1 g/kg/day

Active Comparator group

Treatment:

Dietary Supplement: Glutamine 1 g/kg/day

Enteral Nutrition

Placebo Comparator group

Treatment:

Dietary Supplement: Enteral Nutrition