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

This study has been withdrawn prior to enrollment.
(State of Mass. tightened regulations for making intravenous solutions for research subjects. Study was withdrawn and no participants were enrolled.)
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:
NCT00181753
First received: September 13, 2005
Last updated: January 12, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Burns Drug: standard vs. glutamine enteral or parenteral feeding. Dietary Supplement: Stable isotope tracer study Dietary Supplement: Stable isotope study

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Glutamate and Glutamine Metabolism in Burn Patients Receiving Enteral or Parenteral Nutrition

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: November 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Nutritional Support
  • Glutamine
  • 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:
  • Stable isotopes
  • Glutamine
Dietary Supplement: Stable isotope tracer study
7 hours of primed constant stable isotope tracer infusion.
Other Names:
  • Stable isotope tracers
  • Glutamine
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:
  • Nutritional Support
  • Glutamine
  • 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:
  • Stable isotopes
  • Glutamine
Dietary Supplement: Stable isotope tracer study
7 hours of primed constant stable isotope tracer infusion.
Other Names:
  • Stable isotope tracers
  • Glutamine
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:
  • Nutritional Support
  • Glutamine
  • 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:
  • Stable isotopes
  • Glutamine
Dietary Supplement: Stable isotope tracer study
7 hours of primed constant stable isotope tracer infusion.
Other Names:
  • Stable isotope tracers
  • Glutamine
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:
  • Nutritional Support
  • Glutamine
  • 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:
  • Stable isotopes
  • Glutamine
Dietary Supplement: Stable isotope tracer study
7 hours of primed constant stable isotope tracer infusion.
Other Names:
  • Stable isotope tracers
  • Glutamine
Dietary Supplement: Stable isotope tracer study
7 hours primed constant infusion of stable isotope tracer study
Other Names:
  • Glutamine
  • Stable isotope tracers

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00181753

Locations
United States, Massachusetts
Massachusetts General Hospital Burn Unit
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
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: NCT00181753     History of Changes
Other Study ID Numbers: 2P50GM021700-27A1 ( US NIH Grant/Contract Award Number )
2004-P-001946
Study First Received: September 13, 2005
Last Updated: January 12, 2017

Keywords provided by National Institute of General Medical Sciences (NIGMS):
glutamine metabolic kinetics
glutamate metabolic kinetics
enteral nutrition
parenteral nutrition
burn injury
stable isotopes

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on June 22, 2017