Microcirculation in Cardiac Surgery

Cardiac Disorder Clinical Trial

— MICROCARD  

Official title:

Mesenteric Microcirculatory Function Study Through Sublingual Evaluation During Cardiopulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330745
• Other study ID #: 2009/121/HP
• Status: Completed
• Phase: N/A
• First received: April 5, 2011
• Last updated: September 5, 2014
• Start date: September 2011
• Est. completion date: March 2014

Study information

• Verified date: September 2014
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiac Disorder
• Heart Diseases

Intervention

Other:
• sublingual microcirculatory evaluation
TNF, ICAM, syndecan-1, heparan sulfate

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microcirculatory impairment	Mean flow index measurement and capillar density study	36 months	Yes