Enteral Glutamine Supplementation for the Patient With Major Torso Trauma

Critical Illness Clinical Trial

Official title:

Early Enteral Glutamine Supplement to Enteral Nutrition Support of the Major Torso Trauma Patient: Proposal for a Prospective Randomized Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00178581
• Other study ID #: HSC-MS-05-0144
• Secondary ID: M01RR002558
• Status: Terminated
• Phase: Phase 1
• First received: September 12, 2005
• Last updated: April 22, 2010
• Start date: June 2005
• Est. completion date: September 2006

Study information

• Verified date: December 2007
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Shock
• Trauma
• Wounds and Injuries

Intervention

Drug:
• Glutamine

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut function
Secondary	Systemic appearance of glutamine