Skip to main content
Clinical Trials/NCT00204971
NCT00204971
Completed
Phase 4

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

University of Wisconsin, Madison1 site in 1 country102 target enrollmentJanuary 2003

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Neurologic Injury
Sponsor
University of Wisconsin, Madison
Enrollment
102
Locations
1
Primary Endpoint
Nosocomial infections
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2003
End Date
January 2008
Last Updated
10 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Nosocomial infections

Time Frame: throughout study

Secondary Outcomes

  • Multiple organ dysfunction syndrome(throughout the study)
  • Nutritional outcome parameters(throughout the study)

Study Sites (1)

Loading locations...

Similar Trials