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NCT Number: NCT01219608

Iranian Intensive Care Unit (ICU) Glutamine Study

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.

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Key information

Conditions

Trauma Patients in ICU

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Zahra Hospital

Isfahan, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glutamine 0.5 g/kg/day

Dietary Supplement

Glutamine 0.5 g/kg/day

Glutamine 1 g/kg/day

Dietary Supplement

Glutamine 1 g/kg/day

Enteral Nutrition

Dietary Supplement

Ordinary Enteral Nutrition

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Collaborators

  • Isfahan University of Medical Sciences

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 13, 2010
Registry last updated
Jun 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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