Bioenergetics in Surgical Patients

NCT ID: NCT01890395

Last Updated: 2018-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Mitochondrial DAMP Levels in Surgical Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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blood collection

procedure: Blood draws as the intervention

Group Type OTHER

Blood draws

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of South Alabama

OTHER

Sponsor Role lead

Responsible Party

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William Richards

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William O. Richards, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Alabama, Department of Surgery

Locations

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University of South Alabama Medical Center

Mobile, Alabama, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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William O. Richards, MD

Role: CONTACT

251-471-7993

Facility Contacts

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William O. Richards, MD

Role: primary

251-471-7993

Other Identifiers

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12-294

Identifier Type: -

Identifier Source: org_study_id

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