Enteral Glutamine Supplementation for the Patient With Major Torso Trauma

This study has been terminated.
National Institutes of Health (NIH)
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
First received: September 12, 2005
Last updated: April 22, 2010
Last verified: December 2007
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.

Condition Intervention Phase
Critical Illness
Drug: Glutamine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Enteral Glutamine Supplement to Enteral Nutrition Support of the Major Torso Trauma Patient: Proposal for a Prospective Randomized Clinical Trial

Resource links provided by NLM:

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Gut function

Secondary Outcome Measures:
  • Systemic appearance of glutamine

Estimated Enrollment: 20
Study Start Date: June 2005
Estimated Study Completion Date: September 2006
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00178581

United States, Texas
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Institutes of Health (NIH)
Principal Investigator: Margaret M McQuiggan, MS, RD, CNSD University of Texas Medical School at Houston
  More Information

ClinicalTrials.gov Identifier: NCT00178581     History of Changes
Other Study ID Numbers: HSC-MS-05-0144  M01RR002558 
Study First Received: September 12, 2005
Last Updated: April 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Critical Illness
Enteral Nutrition

Additional relevant MeSH terms:
Critical Illness
Wounds and Injuries
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on February 04, 2016