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

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.

Study Overview

• Status: Unknown
• Conditions: Endothelial Dysfunction; Vasoplegia

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Pierre-Grégoire GUINOT, Doctor; Phone Number: +33 3 22 08 79 80; Email: guinot.pierre-gregoire@chu-amiens.fr
• Study Contact Backup: Name: Mohamed AIT AMER MEZIANE, PHD; Phone Number: +33 3.22.08.83.84; Email: aitamermeziane.mohamed@chu-amiens.fr

Study Locations

• France
  • Caen, France, 14000
    • Recruiting
    • CHU de Caen
    • Contact: Marc-Olivier Fischer
    • Sub-Investigator: Marc-Olivier Fischer, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Pierre-Grégoire GUINOT, Doctor, CHU Amiens Picardie

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: November 14, 2016
• First Submitted That Met QC Criteria: November 15, 2016
• First Posted (Estimate): November 16, 2016

Study Record Updates

• Last Update Posted (Actual): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: cardiac surgery; endothelial dysfunction; Vasoplegia; extracorporeal circulation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Vasoplegia
• Other Study ID Numbers: RNI2015-05 (PI2015-05)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No