Recruiting

Arginine Metabolism

Sponsor:

Massachusetts General Hospital

Code:

NCT00216970

Conditions

Burns

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Alteration in nutritional support

Study Details

Brief summary:

The purpose of the study is to understand the way the body uses amino acids and proteins in burned patient during the time they cannot eat normally. This study aims to understand the metabolism of the amino acid arginine in the body after burn injury. The results of this study will help determine the best composition of food needed during an acute burn injury so that body can more efficiently use the supplied nutrient for optimal burn wound healing and early recovery.

Conditions

Burns

Study ID

NCT00216970

Start date

Aug, 1997

Status verified date

Aug, 2009

Completion date

Dec, 2009

Anticipated

Primary completion date

Dec, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: 1

Patients will receive nutritional support in which the contents of arginine = 0, glutamate = 0 and proline = 0.

Stable isotope tracer studies will be conducted to investigate the whole body protein metabolism and the utilization of arginine in critically ill burn patients.

no intervention: 2

In arm 2 patients will receive nutritional support which will provide glutamine 0.5g/kg/day. Stable isotope tracer studies will be conducted to investigate the whole body protein metabolism and the utilization of arginine in critically ill burn patients.

Interventions

Alteration in nutritional support

The subject is randomized into one of two groups - One receives TPN that does not have arginine, proline or glutamate. The other will receive TPN with extra glutamine. The subject takes part in 3 tracer studies while in the hospital. For each tracer study, the subject will receive a different randomly assigned diet. Blood and air are sampled and the patient receives a stable isotope after which the tests are repeated.

Primary outcome measure

  • This is a nutritional study. The primary outcome is to measure the protein kinetics of amino acid metabolism. Fate will be determine from measurements of subject blood and air samples. [ Time Frame: 18 hours ]

Central Contacts and Locations

Central contacts

Mary-Liz C Bilodeau, MS

617-726-8766mbilodeau@partners.org

Locations

MGH Burn Unit

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Aug 13, 2009

Last verified

Aug, 2009

Keywords

  • parenteral nutrition
  • burn injury
  • stable isotopes
  • Arginine Metabolic Kinetics
  • Nitric Oxide Formation
  • Glutamine Metabolic Kinetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2009-08-13.