Microcirculatory Assessment in Patients With Trauma and Severe Burns

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
William Richards, University of South Alabama
ClinicalTrials.gov Identifier:
NCT01922960
First received: June 27, 2013
Last updated: January 27, 2016
Last verified: January 2016
  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: December 2016
Estimated Primary Completion Date: December 2016 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Alabama
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
  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: January 27, 2016
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 February 07, 2016