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

Endothelial Dysfunction Clinical Trial

— DYVA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02965339
• Other study ID #: RNI2015-05 (PI2015-05)
• Status: Recruiting
• Start date: November 2016
• Est. completion date: November 2018

Study information

• Verified date: April 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Pierre-Grégoire GUINOT, Doctor
• Phone: 3 22 08 79 80
• Email: guinot.pierre-gregoire[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Vasoplegia

Locations

Country	Name	City	State
France	CHU De Caen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

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