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Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients

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ClinicalTrials.gov Identifier: NCT01812941
Recruitment Status : Recruiting
First Posted : March 18, 2013
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
William Richards, University of South Alabama

Brief 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.


Condition or disease Intervention/treatment Phase
Burns Trauma Other: trauma: blood collection Other: healthy volunteers: blood collection Other: Burn: blood collection Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients
Study Start Date : September 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Plasma mtDNA DAMPs concentration [ Time Frame: approximately 1 year to assess outcome measure ]
    Plasma mtDNA DAMPs concentration



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 18, 2013    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016

Keywords provided by William Richards, University of South Alabama:
burns
trauma

Additional relevant MeSH terms:
Wounds and Injuries
Burns