NCT03281317

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,113

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

December 15, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

6 years

First QC Date

September 11, 2017

Last Update Submit

April 9, 2024

Conditions

Vasoplegic Syndrome of Cardiac Surgery

Keywords

vasoplegicsyndromecardiac surgerypredictive risk score

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Post operative organ failure

    30 days

  • Arrythmia

    30 days

  • Inotropic use

    30 days

  • cardiac damage

    1 day

  • Post operative Sepsis

    30 days

  • +5 more secondary outcomes

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, 80054, France

Location

Study Officials

  • Pierre Grégoire guinot.pierregregoire@chu-amiens.fr, Doctor

    guinot.pierregregoire@chu-amiens.fr

    STUDY DIRECTOR

  • Paul Michel MERTES, Professor

    CHU STRASBOURG

    PRINCIPAL INVESTIGATOR

  • Jean-Luc Simon Jean-Baptiste FELLAHI, Professor

    Hospices Civils de 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

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 13, 2017

Study Start

December 15, 2017

Primary Completion

December 15, 2023

Study Completion

December 15, 2024

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations

FR(1)