Enteral Glutamine in Neurologically-Injured Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by University of Wisconsin, Madison.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00204971
First received: September 13, 2005
Last updated: December 26, 2007
Last verified: December 2007

September 13, 2005
December 26, 2007
January 2003
January 2010   (final data collection date for primary outcome measure)
Nosocomial infections [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
Nosocomial infections
Complete list of historical versions of study NCT00204971 on ClinicalTrials.gov Archive Site
  • Multiple organ dysfunction syndrome [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
  • Nutritional outcome parameters [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • -Multiple organ dysfunction syndrome
  • - Nutritional outcome parameters
Not Provided
Not Provided
 
Enteral Glutamine in Neurologically-Injured Patients
Randomized, Placebo-Controlled Clinical Trial of Enteral Glutamine Supplementation 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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Neurologic Injury
  • Traumatic Brain Injury
  • Dietary Supplement: Enteral glutamine powder
    nutritional supplement
  • Other: placebo
    placebo control
  • Experimental: 1
    Nutritional supplement
    Intervention: Dietary Supplement: Enteral glutamine powder
  • Placebo Comparator: 2
    placebo
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
102
Not Provided
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Gordon S Sacks, PharmD 608-262-9491 gssacks@pharmacy.wisc.edu
United States
 
NCT00204971
2002-0409
Not Provided
Gordon Sacks, PharmD., FCCP, BCNSP, University of Wisconsin
University of Wisconsin, Madison
Not Provided
Principal Investigator: Gordon S Sacks, PharmD University of Wisconsin, Madison
University of Wisconsin, Madison
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP