CClinicalTrials.gg
Status unknownNCT01890395Updated Aug 17, 2018

Bioenergetics in Surgical Patients

An interventional study of Blood draws in Mitochondrial DAMP Levels in Surgical Patients, sponsored by University of South Alabama. Status unknown at 1 site in United States. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-08-17.

Sponsored by University of South Alabama · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
19 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Mitochondrial DAMP Levels in Surgical Patients

Keywords

  • mitochondrial DAMPS
03

In context

Lead sponsor

University of South Alabama is the lead sponsor of 28 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

N/A

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Other
    blood collection

    procedure: Blood draws as the intervention

    Other: Blood draws

Interventions

  • OtherBlood 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • University of South Alabama Medical Center
    Mobile, Alabama 36617, United States
    • William O. Richards, MD · Contact · brichards@usouthal.edu · 251-471-7993
    • William O. Richards, MD · Principal investigator
    • Jon Simmons, MD · Sub investigator
    • Mark Gillespie, PhD · Sub investigator
    • Marcus Tan, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01890395
Lead sponsor
University of South Alabama
Responsible party
William Richards (Principal investigator, University of South Alabama) — Principal investigator
First posted
Jul 1, 2013
Start date
Dec 2012
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Aug 17, 2018

Study contacts

William O. Richards, MD
Contact
brichards@usouthal.edu
251-471-7993
William O. Richards, MD
principal investigator · University of South Alabama, Department of Surgery

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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