Clinical trial NCT02965339: Evaluation of the Association Between Pre-existing Endothelial Dysfunction and the Onset of Vasoplegia During Cardiac Surgery With Cardiopulmonary Bypass
Official title: Evaluation of the Association Between Pre-existing Endothelial Dysfunction and the Onset of Vasoplegia During Cardiac Surgery With Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vasoplegia
Endothelial Dysfunction
Keywords: Vasoplegia
endothelial dysfunction
extracorporeal circulation
cardiac surgery
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients ≥ 18 years, operated on for cardiac surgical myocardial revascularization (CABG) or surgical correction of aortic valve.

Consent signed.

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: The primary endpoint was the occurrence of vasoplegic syndrome
timeFrame: 6 months
Secondary outcomes:
measure: Occurrence of vasoplegic syndrome
timeFrame: 6 months
measure: Marker of degradation glycocalyx:
timeFrame: 6 months
measure: Inflammatory markers:
timeFrame: 6 months
measure: Markers of blood coagulation
timeFrame: 6 months
measure: Complications
timeFrame: 6 months
measure: Death
timeFrame: 6 months
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU De Caen
Study officials:
affiliation: CHU Amiens Picardie
name: Pierre-Grégoire GUINOT, Doctor
role: PRINCIPAL_INVESTIGATOR
References: