Effect of Glutamine Supplemented Nutrition Support on Protein and Glutamine Metabolism in Burns
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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:
|
|
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:
|
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 |
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| Contact: Mary-Liz C Bilodeau, MS | 617-726-8766 | mbilodeau@partners.org |
| Contact: Yong-Ming Yu, MD, ScD |
| 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 | |
| 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 May 19, 2013