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Iranian Intensive Care Unit (ICU) Glutamine Study

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ClinicalTrials.gov Identifier: NCT01219608
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : June 14, 2011
Sponsor:
Collaborator:
Isfahan University of Medical Sciences
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Trauma Patients in ICU Dietary Supplement: Glutamine 0.5 g/kg/day Dietary Supplement: Glutamine 1 g/kg/day Dietary Supplement: Enteral Nutrition Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Iranian Intensive Care Unit (ICU) Glutamine Study
Study Start Date : January 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine

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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Prealbumin [ Time Frame: 10 days after intervention ]
    Prealbumin will be measured and will be compared to the baseline after 10 days of the intervention

  2. CRP [ Time Frame: 10 days after intervention ]
    CRP will be measured and will be compared to the baseline after 10 days of the intervention

  3. 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

  4. Length of stay (LOS)
    LOS will be measured and will be compared to the baseline after 10 days of the intervention

  5. 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

  6. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219608


Locations
Iran, Islamic Republic of
Al-Zahra Hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Isfahan University of Medical Sciences

Responsible Party: Dr Reza Rastmanesh, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01219608     History of Changes
Other Study ID Numbers: eums1388
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: June 14, 2011
Last Verified: October 2010