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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02965339
Acronym
DYVA
Enrollment
0
Registered
2016-11-16
Start date
2016-11-01
Completion date
2020-03-02
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Dysfunction, Vasoplegia

Keywords

Vasoplegia, endothelial dysfunction, extracorporeal circulation, cardiac surgery

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.

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
The primary endpoint was the occurrence of vasoplegic syndrome6 monthsThe primary endpoint was the occurrence of vasoplegic syndrome correlate with markers of endothelial function following: IL8, P-selectin, von Willebrand factor precursor.

Secondary

MeasureTime frameDescription
Occurrence of vasoplegic syndrome6 monthsOccurrence of vasoplegic syndrome correlate with markers of endothelial function following: endothelial microparticles, Von Willebrand factor, VCAM1.
Marker of degradation glycocalyx:6 monthsMarker of degradation glycocalyx: syndecan, heparan sulfate.
Inflammatory markers:6 monthsInflammatory markers: leukocytes, CRP, procalcitonin, albumin, TNF alpha, IL-10, IL-6, IL1beta
Markers of blood coagulation6 monthsMarkers of blood coagulation: Platelet count, PT, APTT, fibrinogen, D dimers, soluble complexes.
Complications6 monthsComplications: cardiovascular (vasoplegic syndrome), kidney (KDIGO).
Death6 monthsDeath

Countries

France

Contacts

PRINCIPAL_INVESTIGATORPierre-Grégoire GUINOT, Doctor

CHU Amiens Picardie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026