Vasoplegic Syndrome of Cardiac SurgeryISYVACCNCT03281317
Vasoplegic Syndrome in Cardiac Surgery
An observational study of Vasoplegic Syndrome of Cardiac Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Vasoplegic Syndrome of Cardiac Surgery
- How many people
- 1,113 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2017to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive cardiac surgical patients who meeet inclusion criteria with cardiopulmonary bypass
Who may be able to join
- 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
Who cannot join
- Cardiac graft.
- Preoperative ECMO / ECLS.
- Cardiac assistance.
- Minor,
- Patient deprived of liberty, or under safeguard of justice.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Vasoplegic Syndrome of Cardiac Surgery
- Keywords
- vasoplegicsyndrome, cardiac surgery, predictive risk score
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (10)
Post operative organ failure
every post opertaive organ failure: brain, digestive, renal, cardiac...
Measured: 30 days
Arrythmia
atrial fibrillation, ventricular tachycardia, ventricular flutter
Measured: 30 days
Inotropic use
dobutamine, levosimendan, phosphodiesterase
Measured: 30 days
cardiac damage
troponine I release
Measured: 1 day
Post operative Sepsis
postoperative sepsis: pneumonae, blood stream, mediastinis, urinary track, other
Measured: 30 days
Hemorrhage
postopertaive blood loss defined by the Universal definition of perioperative bleeding
Measured: 30 days
Blood transfusion
red blood cell transfusion, plaquette, plasma
Measured: 30 days
ICU stays
Stay at ICU until patient discharge
Measured: 30 days
Hospital stays
hospital stays until patient discharge
Measured: 30 days
Death
Death of any cause
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start8 Jan 2017
- Primary completion20 Aug 2021
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasoplegic Syndrome of Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Grégoire guinot.pierregregoire@chu-amiens.fr, Doctor, Study director, guinot.pierregregoire@chu-amiens.frPaul Michel MERTES, Professor, Principal investigator, CHU STRASBOURGJean-Luc Simon Jean-Baptiste FELLAHI, Professor, Principal investigator, Hospices Civils de LyonFISCHER Marc Olivier, Professor, Principal investigator, University Hospital, CaenGIRARD Claude, Professor, Principal investigator, CHU DIJONLongrois Dan, Doctor, Principal investigator, APHP, ParisBESNIE Emmanuel, Doctor, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281317
- Sponsor's protocol ID
- PI2017_843_0014
- Acronym
- ISYVACC
- Status last verified
- Jun 2026
- First submitted
- 11 Sep 2017
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Le Syndrome vasoplégique en Post-opératoire de Chirurgie Cardiaque: étude de Construction et de Validation d'un Score prédictif (Etude ISYVACC).
- ClinicalTrials.gov ID
- NCT03281317
- Acronym / sponsor ID
- ISYVACC / PI2017_843_0014
- Conditions
- Vasoplegic Syndrome of Cardiac Surgery
- Keywords
- vasoplegicsyndrome, cardiac surgery, predictive risk score
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,113 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 8 Jan 2017 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive cardiac surgical patients who meeet inclusion criteria with cardiopulmonary bypass
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Cardiac graft.
- Preoperative ECMO / ECLS.
- Cardiac assistance.
- Minor,
- Patient deprived of liberty, or under safeguard of justice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
10 secondary outcomes
Post operative organ failure
Time frame: 30 days
Arrythmia
Time frame: 30 days
Inotropic use
Time frame: 30 days
cardiac damage
Time frame: 1 day
Post operative Sepsis
Time frame: 30 days
Hemorrhage
Time frame: 30 days
Blood transfusion
Time frame: 30 days
ICU stays
Time frame: 30 days
Hospital stays
Time frame: 30 days
Death
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Mic Mac: Micro- and Macrocirculatory Assessment During Cardiac Surgery in Patients at Risk of Vasoplegic Syndrome: A Prospective Study.
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Vasoplegic Syndrome of Cardiac Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vasoplegic Syndrome of Cardiac Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vasoplegic syndrome (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.