Back to resultsEnteral Glutamine Supplementation for the Patient With Major Torso Trauma
Primary Purpose
Trauma, Critical Illness, Shock
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Glutamine
Sponsored by
About this trial
This is an interventional treatment trial for Trauma focused on measuring Trauma, Critical Illness, Shock, Enteral Nutrition, Glutamine
Eligibility 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
Sites / Locations
- University of Texas Health Science Center at Houston
Outcomes
Primary Outcome Measures
Gut function
Secondary Outcome Measures
Systemic appearance of glutamine
Full Information
NCT ID
NCT00178581
First Posted
September 12, 2005
Last Updated
April 22, 2010
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT00178581
Brief Title
Enteral Glutamine Supplementation for the Patient With Major Torso Trauma
Official Title
Early Enteral Glutamine Supplement to Enteral Nutrition Support of the Major Torso Trauma Patient: Proposal for a Prospective Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Terminated
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institutes of Health (NIH)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Critical Illness, Shock
Keywords
Trauma, Critical Illness, Shock, Enteral Nutrition, Glutamine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Glutamine
Primary Outcome Measure Information:
Title
Gut function
Secondary Outcome Measure Information:
Title
Systemic appearance of glutamine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret M McQuiggan, MS, RD, CNSD
Organizational Affiliation
University of Texas Medical School at Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18165444
Citation
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. doi: 10.1177/014860710803200128.
Results Reference
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Enteral Glutamine Supplementation for the Patient With Major Torso Trauma
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