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

Primary Purpose

Burns

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
standard vs. glutamine enteral or parenteral feeding.
Stable isotope tracer study
Stable isotope study
Stable isotope tracer study
Stable isotope tracer study
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring glutamine metabolic kinetics, glutamate metabolic kinetics, enteral nutrition, parenteral nutrition, burn injury, stable isotopes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital Burn Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

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

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

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

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

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
January 12, 2017
Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00181753
Brief Title
Study of Glutamate and Glutamine Metabolism in Burn Patients Receiving Enteral or Parenteral Nutrition
Official Title
Study of Glutamate and Glutamine Metabolism in Burn Patients Receiving Enteral or Parenteral Nutrition
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Withdrawn
Why Stopped
State of Mass. tightened regulations for making intravenous solutions for research subjects. Study was withdrawn and no participants were enrolled.
Study Start Date
November 2009 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
October 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
glutamine metabolic kinetics, glutamate metabolic kinetics, enteral nutrition, parenteral nutrition, burn injury, stable isotopes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Burn Patients receiving at least 3 days of parenteral feeding on routine formula
Arm Title
2
Arm Type
Experimental
Arm Description
Burn patients receiving at least 3 days on parenteral feeding on glutamine enriched formula.
Arm Title
3
Arm Type
Experimental
Arm Description
Burn patients receiving at least 3 days of enteral feeding on routine formula.
Arm Title
4
Arm Type
Experimental
Arm Description
Burn patients receiving at least 3 days of enteral feeding on glutamine-enriched formula.
Intervention Type
Drug
Intervention Name(s)
standard vs. glutamine enteral or parenteral feeding.
Other Intervention Name(s)
Nutritional Support, Glutamine, Glutamate, Amino Acide
Intervention Description
Patient in each group will continue on the same diet for > 3 days before we conduct stable isotope tracer measurements.
Intervention Type
Dietary Supplement
Intervention Name(s)
Stable isotope tracer study
Other Intervention Name(s)
Glutamine, Stable isotope study
Intervention Description
7 hours of primed constant infusion
Intervention Type
Dietary Supplement
Intervention Name(s)
Stable isotope study
Other Intervention Name(s)
Stable isotopes, Glutamine
Intervention Description
7 hours of primed constant infusion of stable isotope tracers.
Intervention Type
Dietary Supplement
Intervention Name(s)
Stable isotope tracer study
Other Intervention Name(s)
Stable isotope tracers, Glutamine
Intervention Description
7 hours of primed constant stable isotope tracer infusion.
Intervention Type
Dietary Supplement
Intervention Name(s)
Stable isotope tracer study
Other Intervention Name(s)
Glutamine, Stable isotope tracers
Intervention Description
7 hours primed constant infusion of stable isotope tracer study
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald G Tompkins, MD, ScD
Organizational Affiliation
MGH, Shriners Burn Hospital-Boston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Burn Unit
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15179374
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. doi: 10.1016/j.surg.2003.11.014.
Results Reference
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PubMed Identifier
11533293
Citation
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.
Results Reference
background
PubMed Identifier
15183630
Citation
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.
Results Reference
background
Links:
URL
http://burnresearchcenter.org
Description
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Study of Glutamate and Glutamine Metabolism in Burn Patients Receiving Enteral or Parenteral Nutrition

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