Microcirculatory Assessment in Patients With Trauma and S... | NCT01922960

Studies
Microcirculatory Assessment in Patients With Trauma and Severe Burns

NCT01922960

Sponsor

University of South Alabama

Status

Withdrawn

Last Update Posted

Nov 29, 2017Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Burns
Trauma

Interventions

micro-imaging

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

investigators decided not to move forward with project

Expanded Access Info

Start Date

Apr 7, 2012Estimated

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Jun 27, 2013

First Submission Date that Met QC Criteria

Aug 12, 2013

First Posted Date

Aug 14, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2017

Last Update Posted Date

Nov 29, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

University of South AlabamaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
micro-imaging	Other	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
micro-imaging	Other	micro-imaging	micro-imaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
dysfunctional capillary density correlates with development of multiple organ failure		approximately 1 year to assess outcome measure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William O Richards, MD	University of South Alabama, Department of Surgery	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of South Alabama Medical Center		Mobile	Alabama	36617	United States

Condition Browse Module

MeSH Terms

ID	Term
D002056	Burns
D014947	Wounds and Injuries
D009102	Multiple Organ Failure

Ancestor Terms

ID	Term
D012769	Shock
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided