Randomized, Placebo-controlled Clinical Trial of Enteral Glutamine Supplementation in Neurologically-injured Patients
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Nosocomial infections
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
1
Nutritional supplement
Intervention: Enteral glutamine powder (Dietary Supplement)
2
placebo
Intervention: placebo (Other)
Outcomes
Primary Outcomes
Nosocomial infections
Time Frame: throughout study
Secondary Outcomes
- Multiple organ dysfunction syndrome(throughout the study)
- Nutritional outcome parameters(throughout the study)