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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Burns
• Trauma
• Wounds and Injuries

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