Enteral Glutamine Supplementation for the Patient With Major Torso Trauma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00178581
Recruitment Status : Terminated
First Posted : September 15, 2005
Last Update Posted : April 23, 2010
National Institutes of Health (NIH)
Information provided by:
The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Trauma Critical Illness Shock Drug: Glutamine Phase 1

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  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2005
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine

Primary Outcome Measures :
  1. Gut function

Secondary Outcome Measures :
  1. Systemic appearance of glutamine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications: Identifier: NCT00178581     History of Changes
Other Study ID Numbers: HSC-MS-05-0144
M01RR002558 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: April 23, 2010
Last Verified: December 2007

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

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