Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01812941

Enrollment

Registered

2013-03-18

Start date

2011-09-30

Completion date

2021-12-31

Last updated

2021-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns, Trauma

Keywords

burns, trauma

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.

Interventions

OTHERtrauma: blood collection

Blood samples collected at certain timepoints. Time points for burn/trauma subjects: Day0,Day1,Day2,and Day6 and Day7.

OTHERhealthy volunteers: blood collection

blood collected at designated time intervals

OTHERBurn: blood collection

blood collected at designated time intervals

Study design

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Plasma mtDNA DAMPs concentration	approximately 1 year to assess outcome measure	Plasma mtDNA DAMPs concentration

Countries

United States

Contacts

Primary ContactJon Simmons, MD

jdsimmons@health.southalabama.edu251-471-7971

Backup ContactMark Gillespie, PHD

mgillesp@southalabama.edu251-460-6497

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026