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

Primary Purpose

Burns

Status
Withdrawn
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Burns focused on measuring parenteral nutrition, burn injury, stable isotopes, Glutamate Metabolic Kinetics, Glutamine Metabolic Kinetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital Burn Unit

Arms of the Study

Arm 1

Arm Type

Arm Label

Burn patients

Arm Description

Receiving standard TPN with or without glutamine enrichment

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
September 20, 2005
Last Updated
November 15, 2016
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00216996
Brief Title
Effect of Glutamine Supplemented Nutrition Support on Protein and Glutamine Metabolism in Burns
Official Title
Study on the Effect of Glutamine Supplemented Nutrition Support on Protein and Glutamine Metabolism in Severely Burned Patients
Study Type
Observational

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
This study was withdrawn (see NCT00181753).
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
parenteral nutrition, burn injury, stable isotopes, Glutamate Metabolic Kinetics, Glutamine Metabolic Kinetics

7. Study Design

Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Burn patients
Arm Description
Receiving standard TPN with or without glutamine enrichment
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald G. Tompkins, MD, ScD
Organizational Affiliation
MGH, Shriners Burn Hospital - Boston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Burn Unit
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Published data will be shared in our publications and directly with an individual researcher when requested.
Citations:
PubMed Identifier
15179374
Citation
Sheridan RL, Prelack K, Yu YM, Lydon M, Petras L, Young VR, Tompkins RG. Short-term enteral glutamine does not enhance protein accretion in burned children: a stable isotope study. Surgery. 2004 Jun;135(6):671-8. doi: 10.1016/j.surg.2003.11.014.
Results Reference
background
PubMed Identifier
11533293
Citation
Young VR, Ajami AM. Glutamine: the emperor or his clothes? J Nutr. 2001 Sep;131(9 Suppl):2449S-59S; discussion 2486S-7S. doi: 10.1093/jn/131.9.2449S.
Results Reference
background
PubMed Identifier
3128190
Citation
Yu YM, Wagner DA, Walesreswski JC, Burke JF, Young VR. A kinetic study of leucine metabolism in severely burned patients. Comparison between a conventional and branched-chain amino acid-enriched nutritional therapy. Ann Surg. 1988 Apr;207(4):421-9. doi: 10.1097/00000658-198804000-00009.
Results Reference
background
Links:
URL
http://www.burnresearchcenter.org
Description
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Effect of Glutamine Supplemented Nutrition Support on Protein and Glutamine Metabolism in Burns

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