NCT00217035

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 1997

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1997

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

12.4 years

First QC Date

September 19, 2005

Last Update Submit

January 12, 2017

Conditions

Burns

Keywords

parenteral nutritionburn injurystable isotopesProline Metabolic KineticsOrnithine Metabolic KineticsGlutamate Metabolic KineticsGlutamine Metabolic Kinetics

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

TPN or TPN enriched with glutamineDIETARY_SUPPLEMENT

Each patient undergoes two nutritional support periods either with or without Glutamine supplementation.

Also known as: Nutritional Support, Amino Acid Composition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Massachusetts General Hospital Burn Unit

Boston, Massachusetts, 02114, United States

Location

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: 18590940BACKGROUND

  • 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. doi: 10.1152/ajpendo.2001.280.3.E509.

    PMID: 11171607BACKGROUND

  • 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. doi: 10.1016/0026-0495(94)90166-x.

    PMID: 8289668BACKGROUND

  • 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. doi: 10.1093/ajcn/54.2.408.

    PMID: 1858705BACKGROUND

  • 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. doi: 10.1016/0026-0495(87)90023-0.

    PMID: 3670073BACKGROUND

MeSH Terms

Conditions

BurnsHyperphagia

Interventions

GlutamineNutritional Support

Condition Hierarchy (Ancestors)

Wounds and InjuriesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, NeutralNutrition TherapyTherapeutics

Study Officials

  • Ronald G Tompkins, MD, ScD

    MGH, Shriners Burn Hospital - Boston

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

August 1, 1997

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

January 13, 2017

Record last verified: 2017-01

Locations

US(1)