Study of Glutamate and Glutamine Metabolism in Burn Patients Receiving Enteral or Parenteral Nutrition

January 12, 2017 updated by: Massachusetts General Hospital
The purpose of the study is to understand how the body uses amino acids in burned patients during the time they cannot eat normally. Amino acids occur naturally in the body and the food we eat. The body combines amino acids to make protein. It uses the proteins to do things such as heal wounds, fight infection, and provide energy. We are studying two ways of receiving nutrition: through a vein or through a tube. We are also studying two different types of food: with or without glutamine. The results of this study will be used to determine the best type and way to supply nutrients during a severe burn injury. We hope to learn how to help the body use nutrients more efficiently to better repair wounded tissues and recover earlier from injury.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

We hypothesize that:

  1. Burn patients will experience an increased conversion of glutamine to glutamate and a decreased conversion of glutamate to glutamine as compared to healthy subjects. The net direction is from glutamine to glutamate in burn patients and would render glutamine as a conditionally essential amino acid.
  2. Because of the limited ability of liver to oxidize glutamate, it is possible that large doses of glutamine may cause increased gluconeogenesis in burn patients, thus aggravating the glucose homeostasis secondary to insulin resistance.
  3. Enterally and parenterally fed glutamine and glutamate have different metabolic fate in the splanchnic bed and peripheral regions, therefore the doses should be tailored according to the route of administration.

This study, using stable isotope tracers, aims to track the metabolic fate of glutamine and glutamate in body with the goal of enhancing nutritional efficiency.

Study Type

Interventional

Phase

  • Not Applicable

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:

  • One or more of the following:

    • 5% Total Body Surface Area Thermal Burn
  • Inhalation Injury
  • Resting Energy Expenditure of >15% of the predicted Basal Metabolic Rate Using Harris-Benedict.
  • Receiving Enteral or Parental Nutritional Support

Exclusion Criteria:

  • Pre-existing:
  • Thyroid disease
  • Congestive Heart Failure (Ejection fraction <20%)
  • Malignancy currently under treatment
  • Medical conditions requiring glucocorticoid treatment
  • Decision not to treat because of severity of injury
  • Presence of Anoxic brain injury with no expectation for recovery
  • Self-Inflicted thermal injury
  • Ileus, gut paralysis, or facial injuries
  • No NG or OG tube as part of their clinical care

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?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Burn Patients receiving at least 3 days of parenteral feeding on routine formula
Drug: standard vs. glutamine enteral or parenteral feeding.
Patient in each group will continue on the same diet for > 3 days before we conduct stable isotope tracer measurements.
Other Names:
  • Glutamine
  • Nutritional Support
  • Glutamate
  • Amino Acide
Dietary supplement: Stable isotope tracer study
7 hours of primed constant infusion
Other Names:
  • Glutamine
  • Stable isotope study
Dietary supplement: Stable isotope study
7 hours of primed constant infusion of stable isotope tracers.
Other Names:
  • Glutamine
  • Stable isotopes
Dietary supplement: Stable isotope tracer study
7 hours of primed constant stable isotope tracer infusion.
Other Names:
  • Glutamine
  • Stable isotope tracers
Dietary supplement: Stable isotope tracer study
7 hours primed constant infusion of stable isotope tracer study
Other Names:
  • Glutamine
  • Stable isotope tracers
Experimental: 2
Burn patients receiving at least 3 days on parenteral feeding on glutamine enriched formula.
Drug: standard vs. glutamine enteral or parenteral feeding.
Patient in each group will continue on the same diet for > 3 days before we conduct stable isotope tracer measurements.
Other Names:
  • Glutamine
  • Nutritional Support
  • Glutamate
  • Amino Acide
Dietary supplement: Stable isotope tracer study
7 hours of primed constant infusion
Other Names:
  • Glutamine
  • Stable isotope study
Dietary supplement: Stable isotope study
7 hours of primed constant infusion of stable isotope tracers.
Other Names:
  • Glutamine
  • Stable isotopes
Dietary supplement: Stable isotope tracer study
7 hours of primed constant stable isotope tracer infusion.
Other Names:
  • Glutamine
  • Stable isotope tracers
Dietary supplement: Stable isotope tracer study
7 hours primed constant infusion of stable isotope tracer study
Other Names:
  • Glutamine
  • Stable isotope tracers
Experimental: 3
Burn patients receiving at least 3 days of enteral feeding on routine formula.
Drug: standard vs. glutamine enteral or parenteral feeding.
Patient in each group will continue on the same diet for > 3 days before we conduct stable isotope tracer measurements.
Other Names:
  • Glutamine
  • Nutritional Support
  • Glutamate
  • Amino Acide
Dietary supplement: Stable isotope tracer study
7 hours of primed constant infusion
Other Names:
  • Glutamine
  • Stable isotope study
Dietary supplement: Stable isotope study
7 hours of primed constant infusion of stable isotope tracers.
Other Names:
  • Glutamine
  • Stable isotopes
Dietary supplement: Stable isotope tracer study
7 hours of primed constant stable isotope tracer infusion.
Other Names:
  • Glutamine
  • Stable isotope tracers
Dietary supplement: Stable isotope tracer study
7 hours primed constant infusion of stable isotope tracer study
Other Names:
  • Glutamine
  • Stable isotope tracers
Experimental: 4
Burn patients receiving at least 3 days of enteral feeding on glutamine-enriched formula.
Drug: standard vs. glutamine enteral or parenteral feeding.
Patient in each group will continue on the same diet for > 3 days before we conduct stable isotope tracer measurements.
Other Names:
  • Glutamine
  • Nutritional Support
  • Glutamate
  • Amino Acide
Dietary supplement: Stable isotope tracer study
7 hours of primed constant infusion
Other Names:
  • Glutamine
  • Stable isotope study
Dietary supplement: Stable isotope study
7 hours of primed constant infusion of stable isotope tracers.
Other Names:
  • Glutamine
  • Stable isotopes
Dietary supplement: Stable isotope tracer study
7 hours of primed constant stable isotope tracer infusion.
Other Names:
  • Glutamine
  • Stable isotope tracers
Dietary supplement: Stable isotope tracer study
7 hours primed constant infusion of stable isotope tracer study
Other Names:
  • Glutamine
  • Stable isotope tracers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
This is a nutritional study. The primary outcome is to measure the protein kinetics for metabolism of the amino acid, glutamate and glutamine. Fate will be determine from measurements of subject blood and air samples.
Time Frame: 3 days and above
3 days and above

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)

Investigators

  • Principal Investigator: Ronald G Tompkins, MD, ScD, MGH, Shriners Burn Hospital-Boston

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

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

November 1, 2009

Primary Completion (Anticipated)

October 1, 2010

Study Completion (Anticipated)

October 1, 2010

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2P50GM021700-27A1 (U.S. NIH Grant/Contract)
  • 2004-P-001946

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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