Study of Glutamate and Glutamine Metabolism in Burn Patients Receiving Enteral or Parenteral Nutrition - Full Text View

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 Endpoint Classification: Efficacy Study 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:

MedlinePlus related topics: Burns Nuclear Scans Nutritional Support

Drug Information available for: Glutamine Glutamic Acid Parenteral Nutrition, Total

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
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:

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.
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.
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
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181753

Contacts

Contact: Mary-Liz C Bilodeau, MS	617-726-8766	mbilodeau@partners.org
Contact: Yong-Ming Yu, PhD, MD	617-724-7766	yyu@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital Burn Unit	Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Mary-Liz C Bilodeau, MS 617-726-8766 mbilodeau@partners.org
Contact: Yong-Ming Yu, MD, PhD 617-724-7766 yyu@partners.org
Sub-Investigator: Colleen M Ryan, MD
Sub-Investigator: Robert L Sheridan, MD
Sub-Investigator: Shawn P Fagan, MD

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:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Sheridan RL, Prelack K, Yu YM, Lydon M, Petras L, Young VR, Tompkins RG. Short-term enteral glutamine does not enhance protein accretion in burned children: a stable isotope study. Surgery. 2004 Jun;135(6):671-8.

Young VR, Ajami AM. Glutamine: the emperor or his clothes? J Nutr. 2001 Sep;131(9 Suppl):2449S-59S; discussion 2486S-7S. Review.

Herndon DN, Tompkins RG. Support of the metabolic response to burn injury. Lancet. 2004 Jun 5;363(9424):1895-902. Review.

Responsible Party:	Ronald G. Tompkins, MD, ScD, Chief, Burn Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00181753 History of Changes
Other Study ID Numbers:	2P50 GM021700-27A1, 2004-P-001946
Study First Received:	September 13, 2005
Last Updated:	August 12, 2009
Health Authority:	United States: Institutional Review Board United States: Federal Government

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 May 21, 2013