Vasoplegic Syndrome in Cardiac Surgery

Vasoplegic Syndrome of Cardiac Surgery Clinical Trial

— ISYVACC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03281317
• Other study ID #: PI2017_843_0014
• Status: Active, not recruiting
• Start date: December 15, 2017
• Est. completion date: December 15, 2024

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1113
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Syndrome
• Vasoplegia
• Vasoplegic Syndrome of Cardiac Surgery

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens

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