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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Institute of General Medical Sciences (NIGMS).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:
NCT00217035
First received: September 19, 2005
Last updated: August 12, 2009
Last verified: August 2009
  Purpose

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 Intervention
Burns
Dietary Supplement: TPN or TPN enriched with glutamine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Glutamine Enriched Total Parenteral Feeding and Proline Metabolism in Severely Burned Patients.

Resource links provided by NLM:


Further study details as provided by National Institute of General Medical Sciences (NIGMS):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: August 1997
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
To study proline balance; the quantitative relationships among proline, ornithine and glutamate with an emphasis on evaluating the rate of proline disposal and conversion to ornithine and glutamate in burn patients.
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
No Intervention: 2
This study serves the purpose of evaluating the conversion rate of ornithine and glutamate to proline and the rate of proline de novo synthesis using stable isotopic tracers.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217035

Contacts
Contact: Mary-Liz C Bilodeau, MS 617-726-8766 mbilodeau@partners.org
Contact: Yong-Ming Yu, PhD, MD

Locations
United States, Massachusetts
Massachusetts General Hospital Burn Unit Recruiting
Boston, Massachusetts, United States, 02114
Sub-Investigator: Robert L Sheridan, MD         
Sub-Investigator: Shawn P Fagan, MD         
Sub-Investigator: Colleen M Ryan, MD         
Sub-Investigator: Yong-Ming Yu, MD, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Ronald G Tompkins, MD, ScD MGH, Shriners Burn Hospital - Boston
  More Information

Additional Information:
Publications:
Responsible Party: Ronald G. Tompkins, MD, ScD, Chief, Burn Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00217035     History of Changes
Other Study ID Numbers: 1999-P-008462, 2P50 GM021700-27
Study First Received: September 19, 2005
Last Updated: August 12, 2009
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

ClinicalTrials.gov processed this record on August 26, 2014