Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Burns Trauma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Burn: blood collection

Procedure: Blood draws as the intervention.

Group Type OTHER

Burn: blood collection

Intervention Type OTHER

blood collected at designated time intervals

trauma: blood collection

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

Group Type OTHER

trauma: blood collection

Intervention Type OTHER

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

Group Type OTHER

healthy volunteers: blood collection

Intervention Type OTHER

blood collected at designated time intervals

Interventions

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trauma: blood collection

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

Intervention Type OTHER

healthy volunteers: blood collection

blood collected at designated time intervals

Intervention Type OTHER

Burn: blood collection

blood collected at designated time intervals

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes