Microcirculatory Assessment in Patients With Trauma and Severe Burns

November 27, 2017 updated by: William Richards, University of South Alabama
Predict the development of multiple organ failure in patients with trauma and severe burns.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Microvascular alterations are frequently seen in patients with sepsis, trauma, burns and those who are hemodynamically uncompensated(Shock).

The use of the Microscan is a non-invasive approach to visualize and assess impaired mucosal microcirculation in order to identify early on patients who are predisposed for MOF (multiple organ failure)

Study Type

Interventional

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
        • University of South Alabama Medical Center

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 with severe burns/trauma ages 19-80. Patients undergoing elective abdominal or cardiothoracic surgery ages 19-69 years old

Exclusion Criteria:

  • Patients undergoing elective surgery < 19 years old.

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: micro-imaging

Sublingual or subconjunctival micro-imaging of the microcirculation taken for 3 minute intervals at certain timepoints.

Timepoints for burn/trauma subjects: Day0, Day1,Day2,Day6 & Day7 Timepoints for general surgery population: post-induction, prior to resection, after resection,& closing of surgical wound.
Other: micro-imaging
micro-imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
dysfunctional capillary density correlates with development of multiple organ failure
Time Frame: approximately 1 year to assess outcome measure
approximately 1 year to assess outcome measure

Collaborators and Investigators

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

Sponsor

University of South Alabama

Investigators

  • Study Chair: 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 (ANTICIPATED)

April 7, 2012

Primary Completion (ACTUAL)

February 1, 2014

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

June 27, 2013

First Submitted That Met QC Criteria

August 12, 2013

First Posted (ESTIMATE)

August 14, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 29, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-092

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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