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

NCT ID: NCT00181753

Last Updated: 2017-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Burn Patients receiving at least 3 days of parenteral feeding on routine formula

Group Type EXPERIMENTAL

standard vs. glutamine enteral or parenteral feeding.

Intervention Type DRUG

Patient in each group will continue on the same diet for \> 3 days before we conduct stable isotope tracer measurements.

Stable isotope tracer study

Intervention Type DIETARY_SUPPLEMENT

7 hours of primed constant infusion

Stable isotope study

Intervention Type DIETARY_SUPPLEMENT

7 hours of primed constant infusion of stable isotope tracers.

Stable isotope tracer study

Intervention Type DIETARY_SUPPLEMENT

7 hours of primed constant stable isotope tracer infusion.

Stable isotope tracer study

Intervention Type DIETARY_SUPPLEMENT

7 hours primed constant infusion of stable isotope tracer study

2

Burn patients receiving at least 3 days on parenteral feeding on glutamine enriched formula.

Group Type EXPERIMENTAL

standard vs. glutamine enteral or parenteral feeding.

Intervention Type DRUG

Patient in each group will continue on the same diet for \> 3 days before we conduct stable isotope tracer measurements.

Stable isotope tracer study

Intervention Type DIETARY_SUPPLEMENT

7 hours of primed constant infusion

Stable isotope study

Intervention Type DIETARY_SUPPLEMENT

7 hours of primed constant infusion of stable isotope tracers.

Stable isotope tracer study

Intervention Type DIETARY_SUPPLEMENT

7 hours of primed constant stable isotope tracer infusion.

Stable isotope tracer study

Intervention Type DIETARY_SUPPLEMENT

7 hours primed constant infusion of stable isotope tracer study

3

Burn patients receiving at least 3 days of enteral feeding on routine formula.

Group Type EXPERIMENTAL

standard vs. glutamine enteral or parenteral feeding.

Intervention Type DRUG

Patient in each group will continue on the same diet for \> 3 days before we conduct stable isotope tracer measurements.

Stable isotope tracer study

Intervention Type DIETARY_SUPPLEMENT

7 hours of primed constant infusion

Stable isotope study

Intervention Type DIETARY_SUPPLEMENT

7 hours of primed constant infusion of stable isotope tracers.

Stable isotope tracer study

Intervention Type DIETARY_SUPPLEMENT

7 hours of primed constant stable isotope tracer infusion.

Stable isotope tracer study

Intervention Type DIETARY_SUPPLEMENT

7 hours primed constant infusion of stable isotope tracer study

4

Burn patients receiving at least 3 days of enteral feeding on glutamine-enriched formula.

Group Type EXPERIMENTAL

standard vs. glutamine enteral or parenteral feeding.

Intervention Type DRUG

Patient in each group will continue on the same diet for \> 3 days before we conduct stable isotope tracer measurements.

Stable isotope tracer study

Intervention Type DIETARY_SUPPLEMENT

7 hours of primed constant infusion

Stable isotope study

Intervention Type DIETARY_SUPPLEMENT

7 hours of primed constant infusion of stable isotope tracers.

Stable isotope tracer study

Intervention Type DIETARY_SUPPLEMENT

7 hours of primed constant stable isotope tracer infusion.

Stable isotope tracer study

Intervention Type DIETARY_SUPPLEMENT

7 hours primed constant infusion of stable isotope tracer study

Interventions

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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.

Intervention Type DRUG

Stable isotope tracer study

7 hours of primed constant infusion

Intervention Type DIETARY_SUPPLEMENT

Stable isotope study

7 hours of primed constant infusion of stable isotope tracers.

Intervention Type DIETARY_SUPPLEMENT

Stable isotope tracer study

7 hours of primed constant stable isotope tracer infusion.

Intervention Type DIETARY_SUPPLEMENT

Stable isotope tracer study

7 hours primed constant infusion of stable isotope tracer study

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Nutritional Support Glutamine Glutamate Amino Acide Glutamine Stable isotope study Stable isotopes Glutamine Stable isotope tracers Glutamine Glutamine Stable isotope tracers

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Massachusetts General Hospital

Principal Investigators

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Ronald G Tompkins, MD, ScD

Role: PRINCIPAL_INVESTIGATOR

MGH, Shriners Burn Hospital-Boston

Locations

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Massachusetts General Hospital Burn Unit

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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. doi: 10.1016/j.surg.2003.11.014.

Reference Type BACKGROUND
PMID: 15179374 (View on PubMed)

Young VR, Ajami AM. Glutamine: the emperor or his clothes? J Nutr. 2001 Sep;131(9 Suppl):2449S-59S; discussion 2486S-7S. doi: 10.1093/jn/131.9.2449S.

Reference Type BACKGROUND
PMID: 11533293 (View on PubMed)

Herndon DN, Tompkins RG. Support of the metabolic response to burn injury. Lancet. 2004 Jun 5;363(9424):1895-902. doi: 10.1016/S0140-6736(04)16360-5.

Reference Type BACKGROUND
PMID: 15183630 (View on PubMed)

Other Identifiers

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2004-P-001946

Identifier Type: -

Identifier Source: secondary_id

2P50GM021700-27A1

Identifier Type: NIH

Identifier Source: org_study_id

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