Enteral Glutamine in Neurologically-injured Patients

Phase 4

Completed

• Conditions: Neurologic Injury; Traumatic Brain Injury
• Interventions: Dietary Supplement: Enteral glutamine powder; Other: placebo

• Registration Number: NCT00204971
• Lead Sponsor: University of Wisconsin, Madison

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-29
• Last Update Posted: 2015-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Enteral glutamine powder	Nutritional supplement
2	placebo	placebo

Primary Outcome Measures

Name	Time	Method
Nosocomial infections	throughout study

Secondary Outcome Measures

Name	Time	Method
Multiple organ dysfunction syndrome	throughout the study
Nutritional outcome parameters	throughout the study

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States