Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients

• Sponsor: University of South Alabama (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT01812941
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 3
• Duration (Months): 123
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Burns; Trauma	Other: trauma: blood collection; Other: healthy volunteers: blood collection; Other: Burn: blood collection	N/A

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 Design

• Study Type: Interventional
• Anticipated 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: Sep 1, 2011
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Burn: blood collection Procedure: Blood draws as the intervention.	Other: Burn: blood collection; blood collected at designated time intervals
Other: 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.
Other: healthy volunteers: blood collection Blood draws as the intervention	Other: healthy volunteers: blood collection; blood collected at designated time intervals

Outcome Measures

Primary Outcome Measures

1. Plasma mtDNA DAMPs concentration [approximately 1 year to assess outcome measure]

   Plasma mtDNA DAMPs concentration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of South Alabama Medical Center	Mobile	Alabama	United States	36617

Sponsors and Collaborators

• University of South Alabama

Investigators

• Principal Investigator: Jon Simmons, MD, University of South Alabama, Department of Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jon Simmons, Principal investigator, University of South Alabama
• ClinicalTrials.gov Identifier: NCT01812941
• Other Study ID Numbers: 11-212
• First Posted: Mar 18, 2013
• Last Update Posted: May 28, 2021
• Last Verified: May 1, 2021

• Keywords provided by Jon Simmons, Principal investigator, University of South Alabama: burns; trauma
• Additional relevant MeSH terms: Wounds and Injuries; Burns

Study Results

No Results Posted as of May 28, 2021