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Active, not recruitingNCT03281317ISYVACCUpdated Jun 15, 2026

Vasoplegic Syndrome in Cardiac Surgery

An observational study in Vasoplegic Syndrome of Cardiac Surgery, sponsored by Centre Hospitalier Universitaire, Amiens. Active, not recruiting at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Centre Hospitalier Universitaire, Amiens · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,113
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Vasoplegic Syndrome of Cardiac Surgery

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Keywords

  • vasoplegicsyndrome
  • cardiac surgery
  • predictive risk score
03

In context

Vasoplegia

48 studies on the registry are indexed under Vasoplegia; 19 are open to participants now.

This study's enrollment of 1,113 is above the median of 200 across 19 observational studies indexed under Vasoplegia.

Browse Vasoplegia studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Cardiac graft.
  • Preoperative ECMO / ECLS.
  • Cardiac assistance.
  • Minor,
  • Patient deprived of liberty, or under safeguard of justice.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,113 participants (actual)
Patient registry
No
06

What researchers measure

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

    Time frame: 30 days

Secondary outcomes

  1. Post operative organ failure

    every post opertaive organ failure: brain, digestive, renal, cardiac...

    Time frame: 30 days

  2. Arrythmia

    atrial fibrillation, ventricular tachycardia, ventricular flutter

    Time frame: 30 days

  3. Inotropic use

    dobutamine, levosimendan, phosphodiesterase

    Time frame: 30 days

  4. cardiac damage

    troponine I release

    Time frame: 1 day

  5. Post operative Sepsis

    postoperative sepsis: pneumonae, blood stream, mediastinis, urinary track, other

    Time frame: 30 days

  6. Hemorrhage

    postopertaive blood loss defined by the Universal definition of perioperative bleeding

    Time frame: 30 days

  7. Blood transfusion

    red blood cell transfusion, plaquette, plasma

    Time frame: 30 days

  8. ICU stays

    Stay at ICU until patient discharge

    Time frame: 30 days

  9. Hospital stays

    hospital stays until patient discharge

    Time frame: 30 days

  10. Death

    Death of any cause

    Time frame: one year

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03281317
Responsible party
Sponsor
First posted
Sep 13, 2017
Start date
Jan 8, 2017
Primary completion
Aug 20, 2021
Completion
Jun 2026 (estimated)
Last update
Jun 15, 2026

Study contacts

Pierre Grégoire guinot.pierregregoire@chu-amiens.fr, Doctor
study director · guinot.pierregregoire@chu-amiens.fr
Paul Michel MERTES, Professor
principal investigator · CHU STRASBOURG
Jean-Luc Simon Jean-Baptiste FELLAHI, Professor
principal investigator · Hospices Civils de Lyon
FISCHER Marc Olivier, Professor
principal investigator · University Hospital, Caen
GIRARD Claude, Professor
principal investigator · CHU DIJON
Longrois Dan, Doctor
principal investigator · APHP, Paris
BESNIE Emmanuel, Doctor
principal investigator · University Hospital, Rouen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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