Enteral Glutamine Supplementation for the Patient With Major Torso Trauma

This study has been terminated.

Sponsors and Collaborators:	The University of Texas Health Science Center, Houston National Institutes of Health (NIH)
Information provided by:	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00178581

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 I

MedlinePlus related topics: Injuries Nutritional Support Wounds

Drug Information available for: Glutamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Early Enteral Glutamine Supplement to Enteral Nutrition Support of the Major Torso Trauma Patient: Proposal for a Prospective Randomized Clinical Trial

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

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

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Margaret M McQuiggan, MS, RD, CNSD

University of Texas Medical School at Houston

More Information

Study ID Numbers:	HSC-MS-05-0144, M01RR002558
Study First Received:	September 12, 2005
Last Updated:	December 7, 2007
ClinicalTrials.gov Identifier:	NCT00178581
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

Study placed in the following topic categories:

Shock
Critical Illness
Wounds and Injuries
Disorders of Environmental Origin

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009