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

January 12, 2017 updated by: Massachusetts General Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Burn Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1997

Primary Completion (ANTICIPATED)

January 1, 2010

Study Completion (ANTICIPATED)

January 1, 2010

Study Registration Dates

First Submitted

September 19, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (ESTIMATE)

September 22, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1999-P-008462
  • 2P50GM021700-27 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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