- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01922960
Microcirculatory Assessment in Patients With Trauma and Severe Burns
Study Overview
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
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Mobile, Alabama, United States, 36617
- University of South Alabama Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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. |
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
Sponsor
Investigators
- Study Chair: William O Richards, MD, University of South Alabama, Department of Surgery
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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