Bioenergetics in Surgical Patients

Not Applicable

• Conditions: Mitochondrial DAMP Levels in Surgical Patients
• Interventions: Other: Blood draws

• Registration Number: NCT01890395
• Lead Sponsor: University of South Alabama

Brief Summary

To identify patients who may be predisposed for developing MOF (multiple organ failure)by the sampling of blood.

Detailed Description

The rationale for doing this study is the recognition that mitochondrial DNA Damage Associated Molecular Patterns (mtDAMPs) accumulate in the circulation after severe injury. Furthermore our own studies in severely injured patients identify that the mtDAMPS are increased 3-28 fold in those patients who eventually develop multiple organ dysfunction syndrome (MODS) compared to those severely traumatized patients who did not develop MODS. The relative risk of death from MODS after severe trauma was increased 8-20 times in those patients with elevated mt DAMP levels.

This study is then being done to correlate mitochondrial damp levels in surgical trauma to assess the time course and the levels of mtDAMPs with the type of surgical procedure. We believe that this information will help us to determine the time course of events and the triggers for development of multiple organ dysfunction seen after surgery.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-06-26
• Study First Submitted QC: 2013-06-26
• Study First Posted: 2013-07-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-17
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients @ USAMC undergoing surgical operations expected to have microcirculatory changes, i.e., CABG, open heart, aortic or other revascularizing operations, general surgical operations such as colon resections, bowel resections or any other surgical procedures in which the subject could be expected to or might develop multiple system organ failure.

Exclusion Criteria

N/A

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
blood collection	Blood draws	procedure: Blood draws as the intervention

Primary Outcome Measures

Name	Time	Method
correlation mitochondrial damps (mDAMPS) and multiple organ system failure	1 year	Preliminary studies (at University of South Alabama)in the trauma and burn patients indicate that the level of mitochondrial damps are highly correlated with non-survival; that is, they reflect a massive trauma. They also reflect patients that have a propensity to go into multiple system organ failure. We believe that these measurements in our surgical patients will also reveal many of the same correlations with the correlation between microvascular circulation and the mitochondrial damps.

Trial Locations

Locations (1)

University of South Alabama Medical Center; 🇺🇸 Mobile, Alabama, United States