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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Neurologic Injury
Traumatic Brain Injury
 Dietary Supplement: Enteral glutamine powder
Other: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Randomized, Placebo-Controlled Clinical Trial of Enteral Glutamine Supplementation in Neurologically-Injured Patients

Resource links provided by NLM:

Drug Information available for: Glutamine
U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Nosocomial infections [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 102
Study Start Date: January 2003
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Nutritional supplement
 Dietary Supplement: Enteral glutamine powder
nutritional supplement
Placebo Comparator: 2
placebo
 Other: placebo
placebo control

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204971

Contacts
Contact: Gordon S Sacks, PharmD 608-262-9491 gssacks@pharmacy.wisc.edu

Locations
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Gordon S Sacks, PharmD., FCCP, BCNSP     608-262-9491     gssacks@pharmacy.wisc.edu    
Principal Investigator: Gordon S Sacks, PharmD            
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Gordon S Sacks, PharmD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Gordon Sacks, PharmD., FCCP, BCNSP, University of Wisconsin
ClinicalTrials.gov Identifier: NCT00204971     History of Changes
Other Study ID Numbers: 2002-0409
Study First Received: September 13, 2005
Last Updated: December 26, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013