Enteral Glutamine in Neurologically-injured Patients

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204971
• Other study ID #: 2002-0409
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: September 29, 2015
• Start date: January 2003
• Est. completion date: January 2008

Study information

• Verified date: September 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neurologic Injury
• Traumatic Brain Injury

Intervention

Dietary Supplement:
• Enteral glutamine powder
nutritional supplement

Other:
• placebo
placebo control

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nosocomial infections		throughout study	Yes
Secondary	Multiple organ dysfunction syndrome		throughout the study	Yes
Secondary	Nutritional outcome parameters		throughout the study	No