Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of South Alabama
Sponsor:
Information provided by (Responsible Party):
William Richards, University of South Alabama
ClinicalTrials.gov Identifier:
NCT01812941
First received: March 13, 2013
Last updated: March 15, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Burns
Trauma
Other: trauma: blood collection
Other: healthy volunteers: blood collection
Other: Burn: blood collection

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients

Resource links provided by NLM:


Further study details as provided by University of South Alabama:

Primary Outcome Measures:
  • Plasma mtDNA DAMPs concentration [ Time Frame: approximately 1 year to assess outcome measure ] [ Designated as safety issue: No ]
    Plasma mtDNA DAMPs concentration


Estimated Enrollment: 50
Study Start Date: September 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Burn: blood collection
Procedure: Blood draws as the intervention.
Other: Burn: blood collection
blood collected at designated time intervals
trauma: blood collection
blood to be collected at different time intervals. Blood draw as the 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 draws as the intervention
Other: healthy volunteers: blood collection
blood collected at designated time intervals

Detailed 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.

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01812941

Contacts
Contact: William O. Richards, MD 251-471-7993 brichards@usouthal.edu
Contact: Cheryl Boothe 251-471-7993 cboothe@usouthal.edu

Locations
United States, Alabama
University of South Alabama Medical Center Recruiting
Mobile, Alabama, United States, 36617
Contact: William O. Richards, MD    251-471-7993    brichards@usouthal.edu   
Principal Investigator: William O. Richards, MD         
Sub-Investigator: Mark Gillespie, PhD         
Sponsors and Collaborators
University of South Alabama
Investigators
Study Chair: William O. Richards, MD University of South Alabama, Department of Surgery
  More Information

No publications provided by University of South Alabama

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: William Richards, Study Chair and Principle Investigator, University of South Alabama
ClinicalTrials.gov Identifier: NCT01812941     History of Changes
Other Study ID Numbers: 11-212
Study First Received: March 13, 2013
Last Updated: March 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Alabama:
burns
trauma

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on July 20, 2014