Microcirculatory Assessment in Patients With Trauma and Severe Burns

Sponsor

University of South Alabama (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01922960

Collaborator

(none)

Enrollment

Location

Arm

21.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Burns Trauma	Other: micro-imaging	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Microcirculatory Assessment in Patients With Trauma and Severe Burns

Anticipated Study Start Date :

Apr 7, 2012

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

dysfunctional capillary density correlates with development of multiple organ failure [approximately 1 year to assess outcome measure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of South Alabama Medical Center	Mobile	Alabama	United States	36617

Sponsors and Collaborators

University of South Alabama

Investigators

Study Chair: William O Richards, MD, University of South Alabama, Department of Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

William Richards, Study Chair and Principle Investigator, University of South Alabama

ClinicalTrials.gov Identifier:

NCT01922960

Other Study ID Numbers:

12-092

First Posted:

Aug 14, 2013

Last Update Posted:

Nov 29, 2017

Last Verified:

Nov 1, 2017

Keywords provided by William Richards, Study Chair and Principle Investigator, University of South Alabama

trauma

multiple organ dysfunction syndrome

Additional relevant MeSH terms:

Wounds and Injuries

Burns

Study Results

No Results Posted as of Nov 29, 2017