Vasoplegic Syndrome in Cardiac Surgery

Le Syndrome vasoplégique en Post-opératoire de Chirurgie Cardiaque: étude de Construction et de Validation d'un Score prédictif (Etude ISYVACC).

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03281317

Acronym

ISYVACC

Enrollment

1113

Registered

2017-09-13

Start date

2017-01-08

Completion date

2026-06-01

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

Vasoplegic Syndrome of Cardiac Surgery

Keywords

vasoplegicsyndrome, cardiac surgery, predictive risk score

Brief summary

Vasoplasmic syndrome in cardiac surgery is one of the major postoperative complications.This syndrome is characterized by persistent low blood pressure despite an optimization of preload and inotropism.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* All patients undergoing cardiac surgery with extracorporeal circulation * Patients covered by a social insurance system. * Patients who have given oral consent to participate after full information

Exclusion criteria

* Cardiac graft. * Preoperative ECMO / ECLS. * Cardiac assistance. * Minor, * Patient deprived of liberty, or under safeguard of justice.

Design outcomes

Primary

Measure	Time frame	Description
Vasoplegic syndrome	30 days	Patients suffering of vasoplegic syndrom defined by persitent arterial hypotension (MAP below70 mmHg) despite fluid rescucitation, normal or high cardiac output, and treated more than 4 hours with norepinephrine

Secondary

Measure	Time frame	Description
Post operative organ failure	30 days	every post opertaive organ failure: brain, digestive, renal, cardiac...
Arrythmia	30 days	atrial fibrillation, ventricular tachycardia, ventricular flutter
Inotropic use	30 days	dobutamine, levosimendan, phosphodiesterase
cardiac damage	1 day	troponine I release
Post operative Sepsis	30 days	postoperative sepsis: pneumonae, blood stream, mediastinis, urinary track, other
Hemorrhage	30 days	postopertaive blood loss defined by the Universal definition of perioperative bleeding
Blood transfusion	30 days	red blood cell transfusion, plaquette, plasma
ICU stays	30 days	Stay at ICU until patient discharge
Hospital stays	30 days	hospital stays until patient discharge
Death	one year	Death of any cause

Countries

France

Contacts

STUDY_DIRECTORPierre Grégoire guinot.pierregregoire@chu-amiens.fr, Doctor

guinot.pierregregoire@chu-amiens.fr

PRINCIPAL_INVESTIGATORPaul Michel MERTES, Professor

CHU STRASBOURG

PRINCIPAL_INVESTIGATORJean-Luc Simon Jean-Baptiste FELLAHI, Professor

Hospices Civils de Lyon

PRINCIPAL_INVESTIGATORFISCHER Marc Olivier, Professor

University Hospital, Caen

PRINCIPAL_INVESTIGATORGIRARD Claude, Professor

CHU DIJON

PRINCIPAL_INVESTIGATORLongrois Dan, Doctor

APHP, Paris

PRINCIPAL_INVESTIGATORBESNIE Emmanuel, Doctor

University Hospital, Rouen

Outcome results