Enteral Glutamine in Neurologically-injured Patients

NCT ID: NCT00204971

Last Updated: 2015-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2008-01-31

Brief Summary

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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

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Conditions

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Neurologic Injury Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Nutritional supplement

Group Type EXPERIMENTAL

Enteral glutamine powder

Intervention Type DIETARY_SUPPLEMENT

nutritional supplement

2

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo control

Interventions

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Enteral glutamine powder

nutritional supplement

Intervention Type DIETARY_SUPPLEMENT

placebo

placebo control

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gordon S Sacks, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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2002-0409

Identifier Type: -

Identifier Source: org_study_id

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