Microcirculation in Cardiac Surgery (MICROCARD)

This study is currently recruiting participants.
Verified September 2012 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01330745
First received: April 5, 2011
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention
Cardiac Disorder
Other: sublingual microcirculatory evaluation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Mesenteric Microcirculatory Function Study Through Sublingual Evaluation During Cardiopulmonary Bypass

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Microcirculatory impairment [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    Mean flow index measurement and capillar density study


Estimated Enrollment: 40
Study Start Date: September 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
aortic valve replacement Other: sublingual microcirculatory evaluation
TNF, ICAM, syndecan-1, heparan sulfate

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330745

Contacts
Contact: Fabien Doguet, MD fabien.doguet@chu-rouen.fr

Locations
France
Rouen University Hospital Recruiting
Rouen, France, 76031
Contact: Fabien DOGUET, MD       fabien.doguet@chu-rouen.fr   
Contact: Patrice TESTUT, PhD       patrice.testut@chu-rouen.fr   
Principal Investigator: Fabien DOGUET, MD         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Fabien Doguet, MD Rouen University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01330745     History of Changes
Other Study ID Numbers: 2009/121/HP
Study First Received: April 5, 2011
Last Updated: September 24, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
cardiopulmonary bypass
mesenteric
microcirculatory function

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014