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Microcirculation in Cardiac Surgery (MICROCARD)

Primary Purpose

Cardiac Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sublingual microcirculatory evaluation
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiac Disorder focused on measuring cardiopulmonary bypass, mesenteric, microcirculatory function

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age> 18 years old
  • aortic valvular disease needing aortic valve replacement

Exclusion Criteria:

  • Age<18 years old
  • emergent cardiac surgery
  • other cardiac surgery

Sites / Locations

  • Rouen University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

aortic valve replacement

Arm Description

Outcomes

Primary Outcome Measures

Microcirculatory impairment
Mean flow index measurement and capillar density study

Secondary Outcome Measures

Full Information

First Posted
April 5, 2011
Last Updated
September 5, 2014
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT01330745
Brief Title
Microcirculation in Cardiac Surgery
Acronym
MICROCARD
Official Title
Mesenteric Microcirculatory Function Study Through Sublingual Evaluation During Cardiopulmonary Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether cardiopulmonary bypass affects mesenteric microcirculatory function, using sublingual evaluation, in cardiac surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disorder
Keywords
cardiopulmonary bypass, mesenteric, microcirculatory function

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aortic valve replacement
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
sublingual microcirculatory evaluation
Intervention Description
TNF, ICAM, syndecan-1, heparan sulfate
Primary Outcome Measure Information:
Title
Microcirculatory impairment
Description
Mean flow index measurement and capillar density study
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age> 18 years old aortic valvular disease needing aortic valve replacement Exclusion Criteria: Age<18 years old emergent cardiac surgery other cardiac surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabien Doguet, MD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

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Microcirculation in Cardiac Surgery

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