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

• Conditions: Endothelial Dysfunction; Vasoplegia

• Registration Number: NCT02965339
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-11-15
• Study First Posted: 2016-11-16
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-01
• Primary Completion: 2018-09
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint was the occurrence of vasoplegic syndrome	6 months	The primary endpoint was the occurrence of vasoplegic syndrome correlate with markers of endothelial function following: IL8, P-selectin, von Willebrand factor precursor.

Secondary Outcome Measures

Name	Time	Method
Markers of blood coagulation	6 months	Markers of blood coagulation: Platelet count, PT, APTT, fibrinogen, D dimers, soluble complexes.
Death	6 months	Death
Complications	6 months	Complications: cardiovascular (vasoplegic syndrome), kidney (KDIGO).
Occurrence of vasoplegic syndrome	6 months	Occurrence of vasoplegic syndrome correlate with markers of endothelial function following: endothelial microparticles, Von Willebrand factor, VCAM1.
Marker of degradation glycocalyx:	6 months	Marker of degradation glycocalyx: syndecan, heparan sulfate.
Inflammatory markers:	6 months	Inflammatory markers: leukocytes, CRP, procalcitonin, albumin, TNF alpha, IL-10, IL-6, IL1beta

Trial Locations

Locations (1)

CHU De Caen; 🇫🇷 Caen, France