Bioenergetics in Surgical Patients

August 15, 2018 updated by: William Richards, University of South Alabama
To identify patients who may be predisposed for developing MOF (multiple organ failure)by the sampling of blood.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36617
        • Recruiting
        • University of South Alabama Medical Center
        • Contact:
        • Principal Investigator:
          • William O. Richards, MD
        • Sub-Investigator:
          • Jon Simmons, MD
        • Sub-Investigator:
          • Marcus Tan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: blood collection
procedure: Blood draws as the intervention
Other: Blood draws
Blood sampling collected at 9 timepoints: pre-operative, during surgery X 3, immediately after surgery, 24 hrs post-op, 72 hrs post-op, 5 days and 7 days post

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation mitochondrial damps (mDAMPS) and multiple organ system failure
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Alabama

Investigators

  • Principal Investigator: William O. Richards, MD, University of South Alabama, Department of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

June 26, 2013

First Submitted That Met QC Criteria

June 26, 2013

First Posted (ESTIMATE)

July 1, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12-294

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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