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Enteral Glutamine in Neurologically-injured Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00204971
First Posted: September 20, 2005
Last Update Posted: October 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  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
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized, Placebo-controlled Clinical Trial of Enteral Glutamine Supplementation in Neurologically-injured Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Nosocomial infections [ Time Frame: throughout study ]

Secondary Outcome Measures:
  • Multiple organ dysfunction syndrome [ Time Frame: throughout the study ]
  • Nutritional outcome parameters [ Time Frame: throughout the study ]

Enrollment: 102
Study Start Date: January 2003
Study Completion Date: January 2008
Primary Completion Date: January 2008 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00204971


Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Gordon S Sacks, PharmD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00204971     History of Changes
Other Study ID Numbers: 2002-0409
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: October 1, 2015
Last Verified: September 2015

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