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

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  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:
NCT00181753
First received: September 13, 2005
Last updated: August 12, 2009
Last verified: August 2009

September 13, 2005
August 12, 2009
November 2009
October 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00181753 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Glutamate and Glutamine Metabolism in Burn Patients Receiving Enteral or Parenteral Nutrition
Study of Glutamate and Glutamine Metabolism in Burn Patients Receiving Enteral or Parenteral Nutrition

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Burns
  • 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: 1
    Burn Patients receiving at least 3 days of parenteral feeding on routine formula
    Interventions:
    • Drug: standard vs. glutamine enteral or parenteral feeding.
    • Dietary Supplement: Stable isotope tracer study
    • Dietary Supplement: Stable isotope study
    • Dietary Supplement: Stable isotope tracer study
    • Dietary Supplement: Stable isotope tracer study
  • Experimental: 2
    Burn patients receiving at least 3 days on parenteral feeding on glutamine enriched formula.
    Interventions:
    • Drug: standard vs. glutamine enteral or parenteral feeding.
    • Dietary Supplement: Stable isotope tracer study
    • Dietary Supplement: Stable isotope study
    • Dietary Supplement: Stable isotope tracer study
    • Dietary Supplement: Stable isotope tracer study
  • Experimental: 3
    Burn patients receiving at least 3 days of enteral feeding on routine formula.
    Interventions:
    • Drug: standard vs. glutamine enteral or parenteral feeding.
    • Dietary Supplement: Stable isotope tracer study
    • Dietary Supplement: Stable isotope study
    • Dietary Supplement: Stable isotope tracer study
    • Dietary Supplement: Stable isotope tracer study
  • Experimental: 4
    Burn patients receiving at least 3 days of enteral feeding on glutamine-enriched formula.
    Interventions:
    • Drug: standard vs. glutamine enteral or parenteral feeding.
    • Dietary Supplement: Stable isotope tracer study
    • Dietary Supplement: Stable isotope study
    • Dietary Supplement: Stable isotope tracer study
    • Dietary Supplement: Stable isotope tracer study

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Mary-Liz C Bilodeau, MS 617-726-8766 mbilodeau@partners.org
Contact: Yong-Ming Yu, PhD, MD 617-724-7766 yyu@partners.org
United States
 
NCT00181753
2P50 GM021700-27A1, 2004-P-001946
Yes
Ronald G. Tompkins, MD, ScD, Chief, Burn Service, Massachusetts General Hospital
Massachusetts General Hospital
National Institutes of Health (NIH)
Principal Investigator: Ronald G Tompkins, MD, ScD MGH, Shriners Burn Hospital-Boston
National Institute of General Medical Sciences (NIGMS)
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP