ISYVACC: Vasoplegic Syndrome in Cardiac Surgery

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Unknown status

CT.gov ID

NCT03281317

Collaborator

(none)

3,000

Enrollment

Location

Anticipated Duration (Months)

83.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vasoplegic Syndrome of Cardiac Surgery

Study Design

Study Type:

Observational

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 15, 2017

Anticipated Primary Completion Date :

Dec 15, 2020

Anticipated Study Completion Date :

Dec 15, 2020

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens Picardie	Amiens		France	80054

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

Study Director: Pierre Grégoire guinot.pierregregoire@chu-amiens.fr, Doctor, guinot.pierregregoire@chu-amiens.fr
Principal Investigator: Paul Michel MERTES, Professor, CHU STRASBOURG
Principal Investigator: Jean-Luc Simon Jean-Baptiste FELLAHI, Professor, CHU LYON
Principal Investigator: FISCHER Marc Olivier, Professor, University Hospital, Caen
Principal Investigator: GIRARD Claude, Professor, CHU DIJON
Principal Investigator: Longrois Dan, Doctor, APHP, Paris
Principal Investigator: BESNIE Emmanuel, Doctor, CHU de Rouen