Postoperative Morbidity and Mortality After Cardiac Surgery
- Conditions
- Cardiac Surgery Under Extra Corporeal Circulation
- Registration Number
- NCT03393169
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
The local database results from a joint initiative of anesthesic, cardiology and cardiac surgery departements.Its purpose is to record in an exhaustive fashion all the interventions of cardiac surgery performed under extracorporeal circulation in adults at Bichat hospital.This database includes the preoperative characteristics of the patients, the type of surgery, the post-operative complications and the in-hospital mortality. The purpose of this observational study is to evaluate in-hospital morbidity and mortality for all types of cardiac surgery interventions and to analyze it according to the characteristics of the patients and the type of intervention.
- Detailed Description
The operative mortality is a key point of the risk-to-benefit ratio analysis before considering cardiac surgery. Operative risk evaluation in a single surgical center is a part of medical care quality assessment. It must be interpreted in the light of the local specificities, in particular the characteristics of the patients and the types of surgery. The local database results from a joint initiative of anesthesic, cardiology and cardiac surgery departements.Its purpose is to record in an exhaustive fashion all the interventions of cardiac surgery performed under extracorporeal circulation in adults at Bichat hospital.This database includes the preoperative characteristics of the patients, the type of surgery, the post-operative complications and the in-hospital mortality. The purpose of this observational study is to evaluate in-hospital morbidity and mortality according to the characteristics of the patients and the type of intervention. study population : inclusion criteria : patient 18 years or older with legal capacity, patients with non-objection to record his/her medical data during hospitalization. Methods: this is an observational prospective and monocentric study. The main objective is to report in-hospital mortality for all types of cardiac surgery performed in Bichat hospital . The secondary objectives are :1) to collect post-operative complications such as hemorrhagic or thromboembolic events or surgery site infections; 2) to analyze mortality rate and post-operative morbidities according to the type of surgery and the main patients' characteristics . 3) to calculate validated and currents risk score such as EuroSCORE I and II for each patient.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 12000
- 18 years and older and has legal capacity - cardiac surgery under extra corporeal circulation
- non objection to record medical information during hospitalization
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All-cause mortality 30 days All-cause mortality is assessed during in-hospital stay and 30 days after the date of surgery
- Secondary Outcome Measures
Name Time Method Postoperative organ failure 30 days Cardiac with inotropic or mechanical support, renal failure or need for dialysis, pulmonary (mechanical ventilation duration), neurologic or digestive complications
Bleeding complications 30 days Total blood loss, transfusion requirements, surgical reexploration
Arrhythmias 30 days Atrial fibrillation, ventricular tachycardia
Conductions disturbances 30 days Need for pace maker implantation
Myocardial injury 30 days Troponin I release (ng/mL)
Postoperative sepsis 30 days Pneumonia, septicemia and endocarditis, surgical site infection
Risk score calculation: Euroscore II 30 days Calculation with all the items required by the published and validated equation
Length of stay 30 days Length of stay in ICU
Trial Locations
- Locations (1)
département de cardiologie et d'anesthésie réanimation Hôpital Bichat 46 rue Henri Huchard
🇫🇷Paris, France