Effect of Glutamine Supplemented Nutrition Support on Protein and Glutamine Metabolism in Burns
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|ClinicalTrials.gov Identifier: NCT00216996|
Recruitment Status : Withdrawn (This study was withdrawn (see NCT00181753).)
First Posted : September 22, 2005
Last Update Posted : November 16, 2016
|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
||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
||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|
|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.|
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 Design||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Burn patients
Receiving standard TPN with or without glutamine enrichment
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
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.
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.
|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|
|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||
|Responsible Party||Ronald G. Tompkins, Massachusetts General Hospital|
|Study Sponsor||Massachusetts General Hospital|
|PRS Account||Massachusetts General Hospital|
|Verification Date||November 2016|