Vasoplegic Syndrome in Cardiac Surgery

Active, not recruiting

• Conditions: Vasoplegic Syndrome of Cardiac Surgery

• Registration Number: NCT03281317
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-11
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-13
• Study Start: 2017-12-15
• Primary Completion: 2023-12-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1113

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
cardiac damage	1 day	troponine I release
Inotropic use	30 days	dobutamine, levosimendan, phosphodiesterase
ICU stays	30 days	Stay at ICU until patient discharge
Post operative organ failure	30 days	every post opertaive organ failure: brain, digestive, renal, cardiac...
Arrythmia	30 days	atrial fibrillation, ventricular tachycardia, ventricular flutter
Death	one year	Death of any cause
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
Hospital stays	30 days	hospital stays until patient discharge

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, France