Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 34 of 68 for:    tpn

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00216996
Recruitment Status : Withdrawn (This study was withdrawn (see NCT00181753).)
First Posted : September 22, 2005
Last Update Posted : November 16, 2016
Sponsor:
Information provided by (Responsible Party):
Ronald G. Tompkins, Massachusetts General Hospital

Tracking Information
First Submitted Date September 20, 2005
First Posted Date September 22, 2005
Last Update Posted Date November 16, 2016
Study Start Date Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: August 19, 2008)
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 ]
Original Primary Outcome Measures
 (submitted: September 20, 2005)
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.
Change History Complete list of historical versions of study NCT00216996 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
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.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Burns
Intervention Not Provided
Study Groups/Cohorts Burn patients
Receiving standard TPN with or without glutamine enrichment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: November 15, 2016)
0
Original Enrollment
 (submitted: September 20, 2005)
16
Study Completion Date Not Provided
Primary Completion Date Not Provided
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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00216996
Other Study ID Numbers 1999-P-008464
5P50GM021700-26 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Published data will be shared in our publications and directly with an individual researcher when requested.
Responsible Party Ronald G. Tompkins, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Ronald G. Tompkins, MD, ScD MGH, Shriners Burn Hospital - Boston
PRS Account Massachusetts General Hospital
Verification Date November 2016