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Trial record 51 of 68 for:    tpn

Proline Metabolism in Severely Burned Patients: Effect of Modulated Parenteral Feeding

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ClinicalTrials.gov Identifier: NCT00216983
Recruitment Status : Withdrawn (State of Mass.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 Study was withdrawn and no participants were enrolled.)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
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
National Institute of General Medical Sciences (NIGMS)

Brief Summary:
The overall purpose of the study is to evaluate the effect of depleting proline supply in the nutritional support regimen on proline metabolism in the burn patients, this includes the rate of proline oxidation after burn injury, the rate of proline de novo synthesis from its immediate precursors glutamate and ornithine. The specific aims of the proposed study are: 1) to determine the kinetic status of proline metabolism and whole body proline balance under the following nutritional states: (a) "fasting; (b) regular total parenteral nutrition (TPN); (c)TPN with isonitrogenous depletion of proline, glutamate and ornithine metabolism under nutritional conditions studied in specific aim 1) above.

Condition or disease
Burns

Detailed Description:

Proline is a non-essential amino acid. Its synthesis and catabolism is via the pathway of ornithine and glutamate, the latter two amino acids serve as its immediate precursors as well as metabolites. Ornithine is one of the intermediates for urea cycle, and 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.

This hypothesis is supported by 1) tissue and circulating glutamine content are reduced in stressed conditions; 2) ornithine disposal via oxidation is significantly increased after burn injury(2). Therefore, the availability of proline is likely to be limiting after burn injury for the synthesis of proteins. On the other hand, proline requirement is significantly increased in burn patients due to the high demand for tissue repair and wound healing. As a result, providing an adequate proportion of its precursors, glutamine / glutamate and / or as preformed proline, is of importance to maintain the appropriate supply and balance of amino acids for protein and other synthetic functions after burn injury.

The overall purpose of the study is to evaluate the effect of depleting proline supply in the nutritional support regimen on proline metabolism in the burn patients, this includes the rate of proline oxidation after burn injury, the rate of proline de novo synthesis from its immediate precursors glutamate and ornithine. The specific aims of the proposed study are: 1) to determine the kinetic status of proline metabolism and whole body proline balance under the following nutritional states: (a) "fasting; (b) regular total parenteral nutrition (TPN); (c)TPN with isonitrogenous depletion of proline, glutamate and ornithine metabolism under nutritional conditions studied in specific aim 1) above.


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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Proline Metabolism in Severely Burned Patients: Effect of Modulated Parenteral Feeding.
Study Start Date : September 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
Drug Information available for: Proline

Group/Cohort
1

Fasting condition to measure:

  1. quantitative relationships among proline, ornithine and glutamate with an emphasis on evaluating the rate of proline disposal and its conversion to ornithine and glutamate in burn patients
  2. Evaluating the rate of proline de novo synthesis from glutamate or ornithine in burn patients
2
We will study the quantitative relationships among proline, ornithine and glutamate with an emphasis on evaluating the rate of proline disposal and its conversion to ornithine and glutamate in burn patients. When the patients are receiving regular TPN or TPN depleted with proline - arginine - glutamate.
3
We wull evaluate the rate of proline de novo synthesis from glutamate or ornithine in burn patients when the patients are receiving regular TPN or TPN depleted proline-arginine-glutamate.



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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Critically ill burn patients
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.


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 ClinicalTrials.gov identifier (NCT number): NCT00216983


Locations
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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)
Investigators
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Principal Investigator: Ronald G Tompkins, MD, ScD MGH, Shriners Burn Hospital - Boston

Additional Information:
Publications:
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Responsible Party: Ronald G. Tompkins, MD, ScD, Chief, Burn Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00216983     History of Changes
Other Study ID Numbers: 1999-P-008463
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