Bioenergetics in Surgical Patients

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

Study Overview

• Status: Unknown
• Conditions: Mitochondrial DAMP Levels in Surgical Patients
• Intervention / Treatment: Other: Blood draws

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

• Study Contact: Name: William O. Richards, MD; Phone Number: 251-471-7993; Email: brichards@usouthal.edu

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36617
      • Recruiting
      • University of South Alabama Medical Center
      • Contact: William O. Richards, MD; Phone Number: 251-471-7993; Email: brichards@usouthal.edu
      • Principal Investigator: William O. Richards, MD
      • Sub-Investigator: Jon Simmons, MD
      • Sub-Investigator: Marcus Tan, MD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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

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

Study record dates

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: mitochondrial DAMPS
• Other Study ID Numbers: 12-294