Enteral Glutamine in Neurologically-injured Patients

University of Wisconsin (UW)

Status and phase: Completed; Phase 4

Conditions: Traumatic Brain Injury; Neurologic Injury

Treatments: Other: placebo; Dietary Supplement: Enteral glutamine powder

Study type: Interventional

Funder types: Other

Identifiers

NCT00204971

2002-0409

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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102 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Nutritional supplement

Treatment:

Dietary Supplement: Enteral glutamine powder

2

Placebo Comparator group

Description:

placebo

Treatment:

Other: placebo