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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
History of Changes
  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:

U.S. FDA Resources

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 June 18, 2013