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Clinical Trials/NCT00178581
NCT00178581
Terminated
Phase 1

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

The University of Texas Health Science Center, Houston1 site in 1 country20 target enrollmentJune 2005

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Trauma
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
20
Locations
1
Primary Endpoint
Gut function
Status
Terminated
Last Updated
16 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
June 2005
End Date
September 2006
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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
  • 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

Outcomes

Primary Outcomes

Gut function

Secondary Outcomes

  • Systemic appearance of glutamine

Study Sites (1)

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