Iranian Intensive Care Unit (ICU) Glutamine Study
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 6, 2010
CompletedFirst Posted
Study publicly available on registry
October 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 14, 2011
October 1, 2010
1.4 years
October 6, 2010
June 13, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
Infection Probability Score
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
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 Outcomes (6)
Prealbumin
10 days after intervention
CRP
10 days after intervention
Serum prealbumin
10 days after the intervention
Length of stay (LOS)
Bed sores
10 days after intervention
- +1 more secondary outcomes
Study Arms (3)
Glutamine 0.5 g/kg/day
ACTIVE COMPARATORGlutamine 1 g/kg/day
ACTIVE COMPARATOREnteral Nutrition
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age 18-60
- No corticosteroids use
- No history of heart, liver and kidney diseases
- Nutrition through nasogastric or orogastric
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Al-Zahra Hospital
Isfahan, Isfahan, Iran
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 6, 2010
First Posted
October 13, 2010
Study Start
January 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
June 14, 2011
Record last verified: 2010-10