CHU Amiens Picardie
Amiens, 80054, France
Active, Not Recruiting
NCT Number: NCT03281317
Vasoplegic Syndrome in Cardiac Surgery
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.
Active, Not Recruiting
This study is active but is not currently recruiting participants.
Notify MeKey information
Conditions
Age range
18 year–100 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
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 outcomes
-
Post operative organ failure
Time frame: 30 days
every post opertaive organ failure: brain, digestive, renal, cardiac...
-
Arrythmia
Time frame: 30 days
atrial fibrillation, ventricular tachycardia, ventricular flutter
-
Inotropic use
Time frame: 30 days
dobutamine, levosimendan, phosphodiesterase
-
cardiac damage
Time frame: 1 day
troponine I release
-
Post operative Sepsis
Time frame: 30 days
postoperative sepsis: pneumonae, blood stream, mediastinis, urinary track, other
-
Hemorrhage
Time frame: 30 days
postopertaive blood loss defined by the Universal definition of perioperative bleeding
-
Blood transfusion
Time frame: 30 days
red blood cell transfusion, plaquette, plasma
-
ICU stays
Time frame: 30 days
Stay at ICU until patient discharge
-
Hospital stays
Time frame: 30 days
hospital stays until patient discharge
-
Death
Time frame: one year
Death of any cause
Sponsors and collaborators
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Other
Registry information
Official study title
Le Syndrome vasoplégique en Post-opératoire de Chirurgie Cardiaque: étude de Construction et de Validation d'un Score prédictif (Etude ISYVACC).
Acronym: ISYVACC
Important dates
- Study start
- 2017
- Primary completion
- 2021
- Study completion
- 2026
- First posted
- Sep 13, 2017
- Registry last updated
- Jun 15, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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