Back to resultsMicrocirculatory Assessment in Patients With Trauma and Severe Burns
Primary Purpose
Burns, Trauma
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
micro-imaging
Sponsored by
About this trial
This is an interventional basic science trial for Burns focused on measuring trauma, multiple organ dysfunction syndrome
Eligibility 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.
Sites / Locations
- University of South Alabama Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
micro-imaging
Arm Description
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.
Outcomes
Primary Outcome Measures
dysfunctional capillary density correlates with development of multiple organ failure
Secondary Outcome Measures
Full Information
NCT ID
NCT01922960
First Posted
June 27, 2013
Last Updated
November 27, 2017
Sponsor
University of South Alabama
1. Study Identification
Unique Protocol Identification Number
NCT01922960
Brief Title
Microcirculatory Assessment in Patients With Trauma and Severe Burns
Official Title
Microcirculatory Assessment in Patients With Trauma and Severe Burns
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Why Stopped
investigators decided not to move forward with project
Study Start Date
April 7, 2012 (Anticipated)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Alabama
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Predict the development of multiple organ failure in patients with trauma and severe burns.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Trauma
Keywords
trauma, multiple organ dysfunction syndrome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
micro-imaging
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
micro-imaging
Intervention Description
micro-imaging
Primary Outcome Measure Information:
Title
dysfunctional capillary density correlates with development of multiple organ failure
Time Frame
approximately 1 year to assess outcome measure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William O Richards, MD
Organizational Affiliation
University of South Alabama, Department of Surgery
Official's Role
Study Chair
Facility Information:
Facility Name
University of South Alabama Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
12. IPD Sharing Statement
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Microcirculatory Assessment in Patients With Trauma and Severe Burns
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