Vasoplegic Syndrome in Cardiac Surgery (ISYVACC)

April 9, 2024 updated by: Centre Hospitalier Universitaire, Amiens

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1113

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens Picardie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All consecutive cardiac surgical patients who meeet inclusion criteria with cardiopulmonary bypass

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vasoplegic syndrome
Time Frame: 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
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2017

Primary Completion (Actual)

December 15, 2023

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

September 11, 2017

First Submitted That Met QC Criteria

September 11, 2017

First Posted (Actual)

September 13, 2017

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2017_843_0014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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