NCT00216996

Brief Summary

The Total Parenteral Nutrition (TPN)received as part of your routine burn care has optimal levels of protein and sugar, however the best mixture of amino acids for a patient with burn wounds is not yet known. 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 if the body's use of protein is increased after receiving TPN containing the amino acid called glutamine. We hope to learn the best composition of TPN so that the body can more efficiently repair wounded tissues and recover earlier from an acute burn injury.

Trial Health

35
At Risk

Trial Health Score

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

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withdrawn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

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2016

First QC Date

September 20, 2005

Last Update Submit

November 15, 2016

Conditions

Keywords

parenteral nutritionburn injurystable isotopesGlutamate Metabolic KineticsGlutamine Metabolic Kinetics

Outcome Measures

Primary Outcomes (1)

  • This is a study for measuring the protein kinetics for metabolism of the amino acid glutamine. Kinetics will be derived from measurements on blood and air samples taken as part of the study.

    15 hours

Study Arms (1)

Burn patients

Receiving standard TPN with or without glutamine enrichment

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 (3)

  • 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.

    PMID: 15179374BACKGROUND
  • 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.

    PMID: 11533293BACKGROUND
  • Yu YM, Wagner DA, Walesreswski JC, Burke JF, Young VR. A kinetic study of leucine metabolism in severely burned patients. Comparison between a conventional and branched-chain amino acid-enriched nutritional therapy. Ann Surg. 1988 Apr;207(4):421-9. doi: 10.1097/00000658-198804000-00009.

    PMID: 3128190BACKGROUND

MeSH Terms

Conditions

BurnsHyperphagia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ronald G. Tompkins, MD, ScD

    MGH, Shriners Burn Hospital - Boston

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Burns Service

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Last Updated

November 16, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

Published data will be shared in our publications and directly with an individual researcher when requested.

Locations