Enteral Glutamine Supplementation for the Patient With Major Torso Trauma

Phase 1

Terminated

• Conditions: Trauma; Critical Illness; Shock

• Registration Number: NCT00178581
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Study Completion: 2006-09
• Status Verified: 2007-12
• Last Update Submitted: 2010-04-22
• Last Update Posted: 2010-04-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gut function

Secondary Outcome Measures

Name	Time	Method
Systemic appearance of glutamine

Trial Locations

Locations (1)

University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States