Iranian Intensive Care Unit (ICU) Glutamine Study

June 13, 2011 updated by: Shahid Beheshti University of Medical Sciences
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Glutamine 0.5 g/kg/day
Dietary supplement: Glutamine 0.5 g/kg/day
Glutamine 0.5 g/kg/day
Active Comparator: Glutamine 1 g/kg/day
Dietary supplement: Glutamine 1 g/kg/day
Glutamine 1 g/kg/day
Placebo Comparator: Enteral Nutrition
Dietary supplement: Enteral Nutrition
Ordinary Enteral Nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection Probability Score
Time Frame: 10 days after intervention
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
Time Frame: 10 days after intervention
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
Time Frame: 10 days after intervention
Prealbumin will be measured and will be compared to the baseline after 10 days of the intervention
10 days after intervention
CRP
Time Frame: 10 days after intervention
CRP will be measured and will be compared to the baseline after 10 days of the intervention
10 days after intervention
Serum prealbumin
Time Frame: 10 days after the intervention
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
Time Frame: 10 days after intervention
Bed sores will be measured and will be compared to the baseline after 10 days of the intervention
10 days after intervention
Mechanical ventilation
Time Frame: 10 days after intervention
Mean mechanical ventilation need will be measured and will be compared to the baseline after 10 days of the intervention
10 days after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Collaborators

Isfahan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

October 6, 2010

First Submitted That Met QC Criteria

October 12, 2010

First Posted (Estimate)

October 13, 2010

Study Record Updates

Last Update Posted (Estimate)

June 14, 2011

Last Update Submitted That Met QC Criteria

June 13, 2011

Last Verified

October 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • eums1388

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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