Glutamine Enriched Total Parenteral Feeding and Proline Metabolism in Severely Burned Patients

Burns Clinical Trial

Official title:

Glutamine Enriched Total Parenteral Feeding and Proline Metabolism in Severely Burned Patients.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00217035
• Other study ID #: 1999-P-008462
• Secondary ID: 2P50GM021700-27
• Status: Withdrawn
• Phase: N/A
• First received: September 19, 2005
• Last updated: January 12, 2017
• Start date: August 1997
• Est. completion date: January 2010

Study information

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

Clinical Trial Summary

Proline is a non-essential amino acid that helps with collagen formation. Collagen is one of the main ingredients of skin, bone, tendons, and connective tissue. It is thought that proline becomes depleted in burn patients because it is being used in greater than normal quantities to help the injured skin and connective tissue heal. If this is true, then the body must look for alternate energy sources as proline becomes depleted.

This study aims to evaluate 1)the metabolic kinetics of the amino acids proline, glutamate, and ornithine and 2) the effects of glutamine supplemented total parenteral nutrition (TPN) on the metabolism of these amino acids.

Description:

Proline is a nutritionally dispensable (non-essential) amino acid. Its synthesis and catabolism is via the pathway of ornithine and glutamate. The latter two amino acids serve as immediate precursors for proline, as well as metabolites. Ornithine is one of the intermediates for urea cycle. Glutamate is metabolically connected to tricarboxylic acid (TCA) cycle, the major cycle for energy production.

It is hypothesized that the significantly increased rates of net nitrogen loss and energy "production", as the consequence of the accelerated activities of both the urea and TCA cycles in burn injury "drain" both ornithine and glutamate, thus depleting tissues of the availability of proline. Hence, the de novo synthesis of proline is likely to be affected by the reduced availability of its major precursors: glutamate and ornithine. We further propose that increased supply of glutamine would increase the de novo synthesis of proline and / or spare the loss of proline via its metabolite glutamate. Hence, glutamine will be beneficial to the overall nutritional status of the burn patients.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Burns

Intervention

Dietary Supplement:
• TPN or TPN enriched with glutamine
Each patient undergoes two nutritional support periods either with or without Glutamine supplementation.

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 (5)

Castillo L, Ajami A, Branch S, Chapman TE, Yu YM, Burke JF, Young VR. Plasma arginine kinetics in adult man: response to an arginine-free diet. Metabolism. 1994 Jan;43(1):114-22. — View Citation

Jaksic T, Wagner DA, Burke JF, Young VR. Plasma proline kinetics and the regulation of proline synthesis in man. Metabolism. 1987 Nov;36(11):1040-6. — View Citation

Jaksic T, Wagner DA, Burke JF, Young VR. Proline metabolism in adult male burned patients and healthy control subjects. Am J Clin Nutr. 1991 Aug;54(2):408-13. — View Citation

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. — View Citation

Yu 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	This is a study for measuring the protein kinetics for metabolism of the amino acids proline, glutamate, and ornithine. Kinetics will be derived from measurements on blood and air samples taken as part of the study.		12 hours

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