Microcirculation in Cardiac Surgery | NCT01330745

Studies
Microcirculation in Cardiac Surgery

NCT01330745

Sponsor

University Hospital, Rouen

Status

Terminated

Last Update Posted

Apr 14, 2026Actual

Enrollment

21Actual

Phase

Not Applicable

Conditions

Cardiac Disorder

Interventions

sublingual microcirculatory evaluation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty in enrolling new patients

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Apr 5, 2011

First Submission Date that Met QC Criteria

Apr 6, 2011

First Posted Date

Apr 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2026

Last Update Posted Date

Apr 14, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
aortic valve replacement	Other		Other: sublingual microcirculatory evaluation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sublingual microcirculatory evaluation	Other	TNF, ICAM, syndecan-1, heparan sulfate	aortic valve replacement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Microcirculatory impairment	Mean flow index measurement and capillar density study	36 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fabien Doguet, MD	University Hospital, Rouen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rouen University Hospital		Rouen		76031	France