NCT00204971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

5 years

First QC Date

September 13, 2005

Last Update Submit

September 29, 2015

Conditions

Neurologic InjuryTraumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Nosocomial infections

    throughout study

Secondary Outcomes (2)

  • Multiple organ dysfunction syndrome

    throughout the study

  • Nutritional outcome parameters

    throughout the study

Study Arms (2)

1

EXPERIMENTAL

Nutritional supplement

Dietary Supplement: Enteral glutamine powder

2

PLACEBO COMPARATOR

placebo

Other: placebo

Interventions

Enteral glutamine powderDIETARY_SUPPLEMENT

nutritional supplement

1
placeboOTHER

placebo control

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Documented hepatic dysfunction
  • Acute renal failure (creatinine clearance \< 15 mL/min)
  • Gastrointestinal malabsorptive disorder
  • Infection at time of admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Gordon S Sacks, PharmD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

January 1, 2003

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

October 1, 2015

Record last verified: 2015-09

Locations

US(1)