NCT01330745

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 7, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

April 5, 2011

Last Update Submit

April 9, 2026

Conditions

Cardiac Disorder

Keywords

cardiopulmonary bypassmesentericmicrocirculatory function

Outcome Measures

Primary Outcomes (1)

  • Microcirculatory impairment

    Mean flow index measurement and capillar density study

    36 months

Study Arms (1)

aortic valve replacement

OTHER
Other: sublingual microcirculatory evaluation

Interventions

sublingual microcirculatory evaluationOTHER

TNF, ICAM, syndecan-1, heparan sulfate

aortic valve replacement

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age\> 18 years old
  • aortic valvular disease needing aortic valve replacement

You may not qualify if:

  • Age\<18 years old
  • emergent cardiac surgery
  • other cardiac surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Fabien Doguet, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2011

First Posted

April 7, 2011

Study Start

September 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations

FR(1)