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Microcirculation in Cardiac Surgery (MICROCARD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01330745
First Posted: April 7, 2011
Last Update Posted: September 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Rouen
  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: None (Open Label)
Primary Purpose: Basic Science
Official Title: Mesenteric Microcirculatory Function Study Through Sublingual Evaluation During Cardiopulmonary Bypass

Further study details as provided by University Hospital, Rouen:

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


Enrollment: 21
Study Start Date: September 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01330745


Locations
France
Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Fabien Doguet, MD Rouen University Hospital
  More Information

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01330745     History of Changes
Other Study ID Numbers: 2009/121/HP
First Submitted: April 5, 2011
First Posted: April 7, 2011
Last Update Posted: September 8, 2014
Last Verified: September 2014

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

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases