Enteral Glutamine Supplementation for the Patient With Major Torso Trauma

April 22, 2010 updated by: The University of Texas Health Science Center, Houston

Early Enteral Glutamine Supplement to Enteral Nutrition Support of the Major Torso Trauma Patient: Proposal for a Prospective Randomized Clinical Trial

Glutamine is considered a conditionally essential amino acid during critical illness. After severe trauma, glutamine supplementation into the gastrointestinal tract may help maintain bowel function. We hypothesize that for the major torso trauma patient, high dose glutamine given enterally during resuscitation from shock and continued during enteral nutrition support is absorbed, available systemically and preserves gut integrity.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

In this prospective, randomized, controlled trial of patients with major torso trauma, high-dose enteral glutamine and enteral nutrition will be given to research subjects while controls will receive isocaloric, isonitrogenous enteral support. Enteral tolerance, bowel integrity and permeability will be evaluated. The systemic appearance of glutamine will be measured.

Study Type

Interventional

Enrollment

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult trauma patients meeting criteria for shock resuscitation
  • Major torso trauma
  • Admission to the Shock/Trauma Intensive Care Unit

Exclusion Criteria:

  • Age <18 years
  • Pregnant
  • Expected survival < 24 hours
  • Bowel in discontinuity
  • Renal failure: baseline serum creatinine>3.0 and/or dialysis
  • Admission total bilirubin >10 mg/dl
  • History of cirrhosis or cirrhosis apparent on exploratory laparotomy
  • Asystole or CPR required

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Gut function

Secondary Outcome Measures

Outcome Measure
Systemic appearance of glutamine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Margaret M McQuiggan, MS, RD, CNSD, University of Texas Medical School at Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion

September 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

April 23, 2010

Last Update Submitted That Met QC Criteria

April 22, 2010

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-05-0144
  • M01RR002558 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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