Evaluation of the Association Between Pre-existing Endothelial Dysfunction and the Onset of Vasoplegia During Cardiac Surgery With Cardiopulmonary Bypass

NCT ID: NCT02965339

Last Updated: 2018-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-11-30

Brief Summary

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Cardiac surgery patients have many risk factors for endothelial dysfunction (hypertension, atherosclerosis, dyslipidemia, chronic renal failure ...).

It is likely that a significant number of patients suffering from a preexisting endothelial dysfunction. This endothelial dysfunction can be assessed by a molecular approach (determination of NO, ICAM1, VCAM1, IL8, endothelial microparticles ...). Extracorporeal circulation with ischemia-reperfusion causes a breach of particularly important glycocalyx as ischemia-reperfusion injury is. No studies have evaluated the time course of the infringement, and its association with the immediate post-operative complications (SIRS, coagulopathy, vasoplegic syndrome, renal failure). Only one study has regained an association between endothelial dysfunction during cardiac bypass surgery and postoperative cardiac surgery vasoplegic syndrome. A study in noncardiac surgery has regained an association between endothelial dysfunction (assessed by a vasoplegia test) and postoperative acute renal failure. Thus there is some data in the literature to suggest that the occurrence of postoperative complications (SIRS, coagulopathy, capillary leak syndrome, acute circulatory failure vasoplegic and acute renal failure) may result from the interaction between a pre-existing endothelial dysfunction and "operative" aggression (extracorporeal circulation). The onset of complications result from an interaction that depends on the importance of endothelial dysfunction at baseline.

Detailed Description

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Conditions

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Vasoplegia Endothelial Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients ≥ 18 years.
* Patient operated on for cardiac surgical myocardial revascularization (CABG) or surgical correction of aortic valve.
* Consent signed.

Exclusion Criteria

* Standing arrhythmia.
* Pregnant woman.
* curative anticoagulation (warfarin, NANCO, heparin).
* Patient under guardianship.
* Patient Refused to participate.
* Cardiac surgery without CPB.
* bicuspid aortic valve.
* Participation in another study.
* preoperative sepsis.
* Minor or major, under guardianship or trusteeship (art L1121-5, L1121-8 and L1122 1-2)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre-Grégoire GUINOT, Doctor

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens Picardie

Locations

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CHU De Caen

Caen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pierre-Grégoire GUINOT, Doctor

Role: CONTACT

3 22 08 79 80 ext. +33

Mohamed AIT AMER MEZIANE, PHD

Role: CONTACT

3.22.08.83.84 ext. +33

Facility Contacts

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Marc-Olivier Fischer

Role: primary

Other Identifiers

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RNI2015-05 (PI2015-05)

Identifier Type: -

Identifier Source: org_study_id

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