Microcirculatory Assessment in Patients With Trauma and Severe Burns

This study is currently recruiting participants.
Verified August 2013 by University of South Alabama
Sponsor:
Information provided by (Responsible Party):
William Richards, University of South Alabama
ClinicalTrials.gov Identifier:
NCT01922960
First received: June 27, 2013
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

Predict the development of multiple organ failure in patients with trauma and severe burns.


Condition Intervention
Burns
Trauma
Other: micro-imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Microcirculatory Assessment in Patients With Trauma and Severe Burns

Resource links provided by NLM:


Further study details as provided by University of South Alabama:

Primary Outcome Measures:
  • dysfunctional capillary density correlates with development of multiple organ failure [ Time Frame: approximately 1 year to assess outcome measure ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01922960

Contacts
Contact: William O Richards, MD 251-471-7993 brichards@usouthal.edu

Locations
United States, Alabama
University of South Alabama Medical Center Recruiting
Mobile, Alabama, United States, 36617
Contact: William O. Richards, MD    251-471-7993    brichards@usouthal.edu   
Principal Investigator: William O. Richards, MD         
Sub-Investigator: Diego Alvarez, PhD         
Sponsors and Collaborators
University of South Alabama
Investigators
Study Chair: William O Richards, MD University of South Alabama, Department of Surgery
  More Information

No publications provided

Responsible Party: William Richards, Study Chair and Principle Investigator, University of South Alabama
ClinicalTrials.gov Identifier: NCT01922960     History of Changes
Other Study ID Numbers: 12-092
Study First Received: June 27, 2013
Last Updated: August 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Alabama:
trauma
multiple organ dysfunction syndrome

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014