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Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients

Primary Purpose

Burns, Trauma

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
trauma: blood collection
healthy volunteers: blood collection
Burn: blood collection
Sponsored by
University of South Alabama
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Burns focused on measuring burns, trauma

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of South Alabama Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Burn: blood collection

trauma: blood collection

healthy volunteers: blood collection

Arm Description

Procedure: Blood draws as the intervention.

blood to be collected at different time intervals. Blood draw as the intervention

Blood draws as the intervention

Outcomes

Primary Outcome Measures

Plasma mtDNA DAMPs concentration
Plasma mtDNA DAMPs concentration

Secondary Outcome Measures

Full Information

First Posted
March 13, 2013
Last Updated
May 26, 2021
Sponsor
University of South Alabama
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1. Study Identification

Unique Protocol Identification Number
NCT01812941
Brief Title
Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients
Official Title
Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Alabama

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Trauma
Keywords
burns, trauma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Burn: blood collection
Arm Type
Other
Arm Description
Procedure: Blood draws as the intervention.
Arm Title
trauma: blood collection
Arm Type
Other
Arm Description
blood to be collected at different time intervals. Blood draw as the intervention
Arm Title
healthy volunteers: blood collection
Arm Type
Other
Arm Description
Blood draws as the intervention
Intervention Type
Other
Intervention Name(s)
trauma: blood collection
Intervention Description
Blood samples collected at certain timepoints. Time points for burn/trauma subjects: Day0,Day1,Day2,and Day6 and Day7.
Intervention Type
Other
Intervention Name(s)
healthy volunteers: blood collection
Intervention Description
blood collected at designated time intervals
Intervention Type
Other
Intervention Name(s)
Burn: blood collection
Intervention Description
blood collected at designated time intervals
Primary Outcome Measure Information:
Title
Plasma mtDNA DAMPs concentration
Description
Plasma mtDNA DAMPs concentration
Time Frame
approximately 1 year to assess outcome measure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jon Simmons, MD
Phone
251-471-7971
Email
jdsimmons@health.southalabama.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Gillespie, PHD
Phone
251-460-6497
Email
mgillesp@southalabama.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Simmons, MD
Organizational Affiliation
University of South Alabama, Department of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Alabama Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon Simmons, MD
Phone
251-471-7971
Email
jdsimmons@southalabama.edu
First Name & Middle Initial & Last Name & Degree
Mark Gillespie, PHD
Phone
251-460-6497
Email
mgillesp@southalabama.edu
First Name & Middle Initial & Last Name & Degree
Jon Simmons, MD
First Name & Middle Initial & Last Name & Degree
Mark Gillespie, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
23979273
Citation
Simmons JD, Lee YL, Mulekar S, Kuck JL, Brevard SB, Gonzalez RP, Gillespie MN, Richards WO. Elevated levels of plasma mitochondrial DNA DAMPs are linked to clinical outcome in severely injured human subjects. Ann Surg. 2013 Oct;258(4):591-6; discussion 596-8. doi: 10.1097/SLA.0b013e3182a4ea46.
Results Reference
derived

Learn more about this trial

Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients

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