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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2009

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2010

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings