Iranian Intensive Care Unit (ICU) Glutamine Study

NCT ID: NCT01219608

Last Updated: 2011-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trauma Patients in ICU

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Glutamine 0.5 g/kg/day

Group Type ACTIVE_COMPARATOR

Glutamine 0.5 g/kg/day

Intervention Type DIETARY_SUPPLEMENT

Glutamine 0.5 g/kg/day

Glutamine 1 g/kg/day

Group Type ACTIVE_COMPARATOR

Glutamine 1 g/kg/day

Intervention Type DIETARY_SUPPLEMENT

Glutamine 1 g/kg/day

Enteral Nutrition

Group Type PLACEBO_COMPARATOR

Enteral Nutrition

Intervention Type DIETARY_SUPPLEMENT

Ordinary Enteral Nutrition

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Glutamine 0.5 g/kg/day

Glutamine 0.5 g/kg/day

Intervention Type DIETARY_SUPPLEMENT

Glutamine 1 g/kg/day

Glutamine 1 g/kg/day

Intervention Type DIETARY_SUPPLEMENT

Enteral Nutrition

Ordinary Enteral Nutrition

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Isfahan University of Medical Sciences

OTHER

Sponsor Role collaborator

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shahid Beheshti University of Medical Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Al-Zahra Hospital

Isfahan, Isfahan, Iran

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Iran

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

eums1388

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Leptin and Ghrelin in ICU
NCT02282501 COMPLETED PHASE4
GlucoClear ICU Study
NCT02238041 WITHDRAWN