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Vasoplegic Syndrome in Cardiac Surgery (ISYVACC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03281317
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.

Condition or disease
Vasoplegic Syndrome of Cardiac Surgery

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Le Syndrome vasoplégique en Post-opératoire de Chirurgie Cardiaque: étude de Construction et de Validation d'un Score prédictif (Etude ISYVACC).
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Post operative organ failure [ Time Frame: 30 days ]
    every post opertaive organ failure: brain, digestive, renal, cardiac...

  2. Arrythmia [ Time Frame: 30 days ]
    atrial fibrillation, ventricular tachycardia, ventricular flutter

  3. Inotropic use [ Time Frame: 30 days ]
    dobutamine, levosimendan, phosphodiesterase

  4. cardiac damage [ Time Frame: 1 day ]
    troponine I release

  5. Post operative Sepsis [ Time Frame: 30 days ]
    postoperative sepsis: pneumonae, blood stream, mediastinis, urinary track, other

  6. Hemorrhage [ Time Frame: 30 days ]
    postopertaive blood loss defined by the Universal definition of perioperative bleeding

  7. Blood transfusion [ Time Frame: 30 days ]
    red blood cell transfusion, plaquette, plasma

  8. ICU stays [ Time Frame: 30 days ]
    Stay at ICU until patient discharge

  9. Hospital stays [ Time Frame: 30 days ]
    hospital stays until patient discharge

  10. Death [ Time Frame: one year ]
    Death of any cause



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive cardiac surgical patients who meeet inclusion criteria with cardiopulmonary bypass
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281317


Contacts
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Contact: Pierre Grégoire GUINOT, Doctor +33 322 087 899 guinot.pierregregoire@chu-amiens.fr

Locations
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France
CHU Amiens Picardie Recruiting
Amiens, France, 80054
Contact: Pierre-Gregoire GUINOT         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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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
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03281317    
Other Study ID Numbers: PI2017_843_0014
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
vasoplegicsyndrome
cardiac surgery
predictive risk score
Additional relevant MeSH terms:
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Vasoplegia
Syndrome
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications