Study of Arginine Metabolism and Nitric Oxide Formation in Relation to Glutamine Supply in Severely Burned Patients
2 other identifiers
interventional
16
1 country
1
Brief Summary
The purpose of the study is to understand the way the body uses amino acids and proteins in burned patient during the time they cannot eat normally. This study aims to understand the metabolism of the amino acid arginine in the body after burn injury. The results of this study will help determine the best composition of food needed during an acute burn injury so that body can more efficiently use the supplied nutrient for optimal burn wound healing and early recovery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 1997
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 1997
CompletedFirst Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedAugust 13, 2009
August 1, 2009
12.3 years
September 16, 2005
August 12, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
This is a nutritional study. The primary outcome is to measure the protein kinetics of amino acid metabolism. Fate will be determine from measurements of subject blood and air samples.
18 hours
Study Arms (2)
1
NO INTERVENTIONPatients will receive nutritional support in which the contents of arginine = 0, glutamate = 0 and proline = 0. Stable isotope tracer studies will be conducted to investigate the whole body protein metabolism and the utilization of arginine in critically ill burn patients.
2
NO INTERVENTIONIn arm 2 patients will receive nutritional support which will provide glutamine 0.5g/kg/day. Stable isotope tracer studies will be conducted to investigate the whole body protein metabolism and the utilization of arginine in critically ill burn patients.
Interventions
The subject is randomized into one of two groups - One receives TPN that does not have arginine, proline or glutamate. The other will receive TPN with extra glutamine. The subject takes part in 3 tracer studies while in the hospital. For each tracer study, the subject will receive a different randomly assigned diet. Blood and air are sampled and the patient receives a stable isotope after which the tests are repeated.
Eligibility Criteria
You may qualify if:
- Burn patients being treated at MGH Burn Unit with one or more of the following criteria: 1) \>=5% TBSA; 2) inhalation injury; or 3) resting energy expenditure (REE) of \>15% of the predicted Basal Metabolic Rate using the Harris-Benedict equation.
- Must be receiving total parenteral nutrition in the course of their treatment.
You may not qualify if:
- Patients with thyroid disease
- Patients who are not hemodynamically stable or show unstable vital signs
- Patients at the stage of major organ failure, e.g. renal and/or liver failure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MGH Burn Unit
Boston, Massachusetts, 02114, United States
Related Publications (5)
Tharakan JF, Yu YM, Zurakowski D, Roth RM, Young VR, Castillo L. Adaptation to a long term (4 weeks) arginine- and precursor (glutamate, proline and aspartate)-free diet. Clin Nutr. 2008 Aug;27(4):513-22. doi: 10.1016/j.clnu.2008.04.014. Epub 2008 Jun 30.
PMID: 18590940BACKGROUNDYu YM, Ryan CM, Castillo L, Lu XM, Beaumier L, Tompkins RG, Young VR. Arginine and ornithine kinetics in severely burned patients: increased rate of arginine disposal. Am J Physiol Endocrinol Metab. 2001 Mar;280(3):E509-17. doi: 10.1152/ajpendo.2001.280.3.E509.
PMID: 11171607BACKGROUNDYu YM, Ryan CM, Burke JF, Tompkins RG, Young VR. Relations among arginine, citrulline, ornithine, and leucine kinetics in adult burn patients. Am J Clin Nutr. 1995 Nov;62(5):960-8. doi: 10.1093/ajcn/62.5.960.
PMID: 7572742BACKGROUNDCastillo L, DeRojas-Walker T, Yu YM, Sanchez M, Chapman TE, Shannon D, Tannenbaum S, Burke JF, Young VR. Whole body arginine metabolism and nitric oxide synthesis in newborns with persistent pulmonary hypertension. Pediatr Res. 1995 Jul;38(1):17-24. doi: 10.1203/00006450-199507000-00004.
PMID: 7478791BACKGROUNDYu YM, Young VR, Castillo L, Chapman TE, Tompkins RG, Ryan CM, Burke JF. Plasma arginine and leucine kinetics and urea production rates in burn patients. Metabolism. 1995 May;44(5):659-66. doi: 10.1016/0026-0495(95)90125-6.
PMID: 7752916BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald G. Tompkins, MD, ScD
MGH, Shriner's Burn Hospital -Boston
Central Study Contacts
Yong-Ming Yu, MD, PhD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 22, 2005
Study Start
August 1, 1997
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
August 13, 2009
Record last verified: 2009-08