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Enteral Glutamine in Neurologically-injured Patients

Primary Purpose

Neurologic Injury, Traumatic Brain Injury

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Enteral glutamine powder
placebo
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neurologic Injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Nutritional supplement

placebo

Outcomes

Primary Outcome Measures

Nosocomial infections

Secondary Outcome Measures

Multiple organ dysfunction syndrome
Nutritional outcome parameters

Full Information

First Posted
September 13, 2005
Last Updated
September 29, 2015
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT00204971
Brief Title
Enteral Glutamine in Neurologically-injured Patients
Official Title
Randomized, Placebo-controlled Clinical Trial of Enteral Glutamine Supplementation in Neurologically-injured Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurologic Injury, Traumatic Brain Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Nutritional supplement
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Enteral glutamine powder
Intervention Description
nutritional supplement
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo control
Primary Outcome Measure Information:
Title
Nosocomial infections
Time Frame
throughout study
Secondary Outcome Measure Information:
Title
Multiple organ dysfunction syndrome
Time Frame
throughout the study
Title
Nutritional outcome parameters
Time Frame
throughout the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon S Sacks, PharmD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

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Enteral Glutamine in Neurologically-injured Patients

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