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Completed

NCT Number: NCT00204971

Enteral Glutamine in Neurologically-injured Patients

Nutrition is an important part of the recovery process after having a head injury so that subjects can gain strength and fight off infection. Liquid nutrition formulas are often given to patients through a tube that has been placed into the intestines for feeding when they are unable to eat on their own. Some reports suggest that nutrition with extra amounts of the amino acid called glutamine may decrease infections and hospital stay in severely injured patients.The purpose of this study is to evaluate if giving extra amounts of an amino acid called glutamine with liquid nutrition formulas will decrease the risk of infection and length of stay in the intensive care unit after having a head injury.

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Key information

Conditions

Neurologic Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Traumatic Brain Injury Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males
  • Nonpregnant females
  • Aged 18-75 years old
  • Glasgow Coma Scores of 3-12
  • Injury Severity Scores greater than or equal to 20
  • Requiring enteral nutrition for a minimum of 5 days

Exclusion criteria

  • Documented hepatic dysfunction
  • Acute renal failure (creatinine clearance < 15 mL/min)
  • Gastrointestinal malabsorptive disorder
  • Infection at time of admission

Treatment and study plan

Enteral glutamine powder

Dietary Supplement

nutritional supplement

Placebo

Other

placebo control

Primary outcomes

  1. Nosocomial infections

    Time frame: throughout study

Secondary outcomes

  1. Multiple organ dysfunction syndrome

    Time frame: throughout the study

  2. Nutritional outcome parameters

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Randomized, Placebo-controlled Clinical Trial of Enteral Glutamine Supplementation in Neurologically-injured Patients

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Sep 20, 2005
Registry last updated
Oct 1, 2015

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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