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NCT01812941 Clinical Trial

Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients

Trauma Clinical Trial

Official title:
Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01812941
Other study ID # 11-212
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 2011
Est. completion date December 2021

Study information
Verified date May 2021
Source University of South Alabama
Contact Jon Simmons, MD
Phone 251-471-7971
Email jdsimmons@health.southalabama.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this project is to evaluate the level of mitochondrial dysfunction several patient populations: Burn, trauma, and control group of healthy volunteers. Study hypothesis: Increased plasma concentrations of a newly discovered inflammatory mediated, called mtDNA DAMPS associated with the occurrence of multi-organ dysfunction syndrome in severly injured patients. As the severity of a burn injury or trauma injury increase, so will systemic mitochondrial dysfunction.

Description:

Increased plasma concentrations of a newly discovered inflammatory mediated, called mtDNA DAMPS associated with the occurrence of multi-organ dysfunction syndrome in severly injured patients. A normal healthy sub-population will be used as a control.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 70 Years
Eligibility Inclusion Criteria: - Burn injury must be less than 24 hours old at time of initial sampling - Burn must be 2nd or 3rd degree and at least 10% TBSA - ISS (injury severity score) > 15 Exclusion Criteria: - Burn injury/trauma injury > than 24hours old at time of initial sampling - Burn < 10% total body surface area. - Evidence of active infection on admission in the burn subjects. - < 19 years of age and > 70 years

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• trauma: blood collection
Blood samples collected at certain timepoints. Time points for burn/trauma subjects: Day0,Day1,Day2,and Day6 and Day7.
• healthy volunteers: blood collection
blood collected at designated time intervals
• Burn: blood collection
blood collected at designated time intervals

Locations
Country Name City State
United States University of South Alabama Medical Center Mobile Alabama

Sponsors (1)
Lead Sponsor Collaborator
University of South Alabama

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma mtDNA DAMPs concentration Plasma mtDNA DAMPs concentration approximately 1 year to assess outcome measure
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