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Enteral Glutamine Supplementation for the Patient With Major Torso Trauma

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ClinicalTrials.gov 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

September 12, 2005
September 15, 2005
April 23, 2010
June 2005
Not Provided
Gut function
Same as current
Complete list of historical versions of study NCT00178581 on ClinicalTrials.gov Archive Site
Systemic appearance of glutamine
Same as current
Not Provided
Not Provided
Enteral Glutamine Supplementation for the Patient With Major Torso Trauma
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.
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.
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Trauma
  • Critical Illness
  • Shock
Drug: Glutamine
Not Provided
McQuiggan M, Kozar R, Sailors RM, Ahn C, McKinley B, Moore F. Enteral glutamine during active shock resuscitation is safe and enhances tolerance of enteral feeding. JPEN J Parenter Enteral Nutr. 2008 Jan-Feb;32(1):28-35.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2006
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
M01RR002558 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
Not Provided
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
The University of Texas Health Science Center, Houston
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP