Enteral Glutamine Supplementation for the Patient With Major Torso Trauma

This study has been terminated.
Sponsor:
Collaborator:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00178581
First received: September 12, 2005
Last updated: April 22, 2010
Last verified: December 2007
  Purpose

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
Trauma
Critical Illness
Shock
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Investigators
Principal Investigator: Margaret M McQuiggan, MS, RD, CNSD University of Texas Medical School at Houston
  More Information

Publications:
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:
Trauma
Critical Illness
Shock
Enteral Nutrition
Glutamine

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

ClinicalTrials.gov processed this record on August 20, 2014