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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00181753
• Other study ID #: 2P50GM021700-27A1
• Secondary ID: 2004-P-001946
• Status: Withdrawn
• Phase: N/A
• First received: September 13, 2005
• Last updated: January 12, 2017
• Start date: November 2009
• Est. completion date: October 2010

Study information

• Verified date: January 2017
• Source: National Institute of General Medical Sciences (NIGMS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns

Intervention

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.

Dietary Supplement:
• Stable isotope tracer study
7 hours of primed constant infusion
• Stable isotope study
7 hours of primed constant infusion of stable isotope tracers.
• Stable isotope tracer study
7 hours of primed constant stable isotope tracer infusion.
• Stable isotope tracer study
7 hours primed constant infusion of stable isotope tracer study

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Burn Unit	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 days and above

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