Effect of Glutamine Supplemented Nutrition Support on Protein and Glutamine Metabolism in Burns

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Institute of General Medical Sciences (NIGMS).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:
NCT00216996
First received: September 20, 2005
Last updated: August 12, 2009
Last verified: August 2009
  Purpose

The Total Parenteral Nutrition (TPN)received as part of your routine burn care has optimal levels of protein and sugar, however the best mixture of amino acids for a patient with burn wounds is not yet known. Amino acids occur naturally in the body and the food we eat. The body combines amino acids to make protein. It uses the proteins to do things such as heal wounds, fight infection, and provide energy. We are studying if the body's use of protein is increased after receiving TPN containing the amino acid called glutamine. We hope to learn the best composition of TPN so that the body can more efficiently repair wounded tissues and recover earlier from an acute burn injury.


Condition Intervention
Burns
Drug: glutamine enriched TPN vs. standard TPN .

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study on the Effect of Glutamine Supplemented Nutrition Support on Protein and Glutamine Metabolism in Severely Burned Patients

Resource links provided by NLM:


Further study details as provided by National Institute of General Medical Sciences (NIGMS):

Primary Outcome Measures:
  • This is a study for measuring the protein kinetics for metabolism of the amino acid glutamine. Kinetics will be derived from measurements on blood and air samples taken as part of the study. [ Time Frame: 15 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: August 1997
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
We will assess protein metabolism and nitrogen waste in burn patients receiving either conventional TPN or nutritional support with enriched glutamine. Stable isotope tracer studies will be conducted using L- [1-13C, 15H] Leucine and [15N2] urea.
Drug: glutamine enriched TPN vs. standard TPN .
Subjects are randomized into one of two groups. Each group receives different diets adn different stable isotopes. Blood and air samples will be obtained at different points in the study.
Other Names:
  • Nutritional Support
  • Glutamine Metabolism
No Intervention: 2

We will directly measure total glutamine metabolism (its endogenous production rate) in burn patients receiving either conventional TPN or TPN with enriched glutamine.

Stable isotope tracers L-[2-15N]glutamine and [5552H3] Leucine will be used.

Drug: glutamine enriched TPN vs. standard TPN .
Subjects are randomized into one of two groups. Each group receives different diets adn different stable isotopes. Blood and air samples will be obtained at different points in the study.
Other Names:
  • Nutritional Support
  • Glutamine Metabolism

Detailed Description:

Human and animal studies have demonstrated that glutamine catabolism exceeds glutamine synthesis in burn patients, resulting in a glutamine-depleted status, which compromises liver function, including glutathione status, proline and arginine homeostasis and whole body protein balance (1). The purpose of this study is to directly quantify glutamine / glutamate kinetics in relation to glutamine / glutamate disposal and whole body amino acid balance, by using stable isotope tracers [1-13C, 15N]leucine and [15N2]urea.

We hypothesize that the enrichment of amino acid mixtures with glutamine will attenuate overall body nitrogen catabolism and better maintain proline and arginine homeostasis.

The purpose of this study it to 1) investigate the effect of glutamine supplemented total parenteral nutrition (TPN) on whole body metabolic and disposal rate of glutamine, and its rate of de novo synthesis in severely burned patients and 2)explore the impact of glutamine supplementation on whole body protein turnover, studied with L-[1-13C, 15N}-leucine, and on the metabolic homeostasis of urea cycle.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Burn patients being treated at MGH Burn Unit with one or more of the following criteria: 1) >=5% TBSA; 2) inhalation injury; or 3) resting energy expenditure (REE) of >15% of the predicted Basal Metabolic Rate using the Harris-Benedict equation.

Must be receiving total parenteral nutrition in the course of their treatment.

Exclusion Criteria:

Patients with thyroid disease. Patients who are not hemodynamically stable or show unstable vital signs Patients at the stage of major organ failure, e.g. renal and/or liver failure.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216996

Contacts
Contact: Mary-Liz C Bilodeau, MS 617-726-8766 mbilodeau@partners.org
Contact: Yong-Ming Yu, MD, ScD

Locations
United States, Massachusetts
Massachusetts General Hospital Burn Unit Recruiting
Boston, Massachusetts, United States, 02114
Sub-Investigator: Shawn P. Fagan, MD         
Sub-Investigator: Robert L. Sheridan, MD         
Sub-Investigator: Colleen M. Ryan, MD         
Sub-Investigator: Yong-Ming Yu, MD, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Ronald G. Tompkins, MD, ScD MGH, Shriners Burn Hospital - Boston
  More Information

Additional Information:
Publications:
Responsible Party: Ronald G. Tompkins, MD, ScD, Chief, Burn Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00216996     History of Changes
Other Study ID Numbers: 1999-P-008464, 2P50 GM021700-27
Study First Received: September 20, 2005
Last Updated: August 12, 2009
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by National Institute of General Medical Sciences (NIGMS):
parenteral nutrition
burn injury
stable isotopes
Glutamate Metabolic Kinetics
Glutamine Metabolic Kinetics

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on October 19, 2014