Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients

University of South Alabama (USA)

Status: Unknown

Conditions: Trauma; Burns

Treatments: Other: trauma: blood collection; Other: healthy volunteers: blood collection; Other: Burn: blood collection

Study type: Interventional

Funder types: Other

Identifiers

NCT01812941

11-212

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Burn: blood collection

Other group

Description:

Procedure: Blood draws as the intervention.

Treatment:

Other: Burn: blood collection

trauma: blood collection

Other group

Description:

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

Treatment:

Other: trauma: blood collection

healthy volunteers: blood collection

Other group

Description:

Blood draws as the intervention

Treatment:

Other: healthy volunteers: blood collection