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Glutamine Enriched Total Parenteral Feeding and Proline Metabolism in Severely Burned Patients

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. Identifier: NCT00217035
Recruitment Status : Withdrawn (State of Mass. tightened regulations for making intravenous solutions for research subjects. Study was withdrawn and no participants were enrolled.)
First Posted : September 22, 2005
Last Update Posted : January 13, 2017
National Institutes of Health (NIH)
Information provided by:
National Institute of General Medical Sciences (NIGMS)

Brief Summary:

Proline is a non-essential amino acid that helps with collagen formation. Collagen is one of the main ingredients of skin, bone, tendons, and connective tissue. It is thought that proline becomes depleted in burn patients because it is being used in greater than normal quantities to help the injured skin and connective tissue heal. If this is true, then the body must look for alternate energy sources as proline becomes depleted.

This study aims to evaluate 1)the metabolic kinetics of the amino acids proline, glutamate, and ornithine and 2) the effects of glutamine supplemented total parenteral nutrition (TPN) on the metabolism of these amino acids.

Condition or disease Intervention/treatment
Burns Dietary Supplement: TPN or TPN enriched with glutamine

Detailed Description:

Proline is a nutritionally dispensable (non-essential) amino acid. Its synthesis and catabolism is via the pathway of ornithine and glutamate. The latter two amino acids serve as immediate precursors for proline, as well as metabolites. Ornithine is one of the intermediates for urea cycle. Glutamate is metabolically connected to tricarboxylic acid (TCA) cycle, the major cycle for energy production.

It is hypothesized that the significantly increased rates of net nitrogen loss and energy "production", as the consequence of the accelerated activities of both the urea and TCA cycles in burn injury "drain" both ornithine and glutamate, thus depleting tissues of the availability of proline. Hence, the de novo synthesis of proline is likely to be affected by the reduced availability of its major precursors: glutamate and ornithine. We further propose that increased supply of glutamine would increase the de novo synthesis of proline and / or spare the loss of proline via its metabolite glutamate. Hence, glutamine will be beneficial to the overall nutritional status of the burn patients.

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Study Type : Observational
Actual Enrollment : 0 participants
Official Title: Glutamine Enriched Total Parenteral Feeding and Proline Metabolism in Severely Burned Patients.
Study Start Date : August 1997
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Intervention Details:
  • Dietary Supplement: TPN or TPN enriched with glutamine
    Each patient undergoes two nutritional support periods either with or without Glutamine supplementation.
    Other Names:
    • Nutritional Support
    • Amino Acid Composition

Primary Outcome Measures :
  1. This is a study for measuring the protein kinetics for metabolism of the amino acids proline, glutamate, and ornithine. Kinetics will be derived from measurements on blood and air samples taken as part of the study. [ Time Frame: 12 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00217035

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United States, Massachusetts
Massachusetts General Hospital Burn Unit
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
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Principal Investigator: Ronald G Tompkins, MD, ScD MGH, Shriners Burn Hospital - Boston

Additional Information:
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Responsible Party: Ronald G. Tompkins, MD, ScD, Chief, Burn Service, Massachusetts General Hospital Identifier: NCT00217035     History of Changes
Other Study ID Numbers: 1999-P-008462
2P50GM021700-27 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017

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