Clinical trial NCT03393169: Postoperative Morbidity and Mortality After Cardiac Surgery
Official title: Evaluation of Post-operative Morbidity and Mortality After Cardiac Surgery Performed in Bichat Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Surgery Under Extra Corporeal Circulation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 12000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients , 18 years old and older, with a cardiac surgery under extra corporeal circulation in Bichat Hospital

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.

Eligibility criteria: Inclusion Criteria:

* 18 years and older and has legal capacity - cardiac surgery under extra corporeal circulation
* non objection to record medical information during hospitalization

Exclusion Criteria:

-

Primary outcomes:
measure: All-cause mortality
timeFrame: 30 days
Secondary outcomes:
measure: Postoperative organ failure
timeFrame: 30 days
measure: Bleeding complications
timeFrame: 30 days
measure: Arrhythmias
timeFrame: 30 days
measure: Conductions disturbances
timeFrame: 30 days
measure: Myocardial injury
timeFrame: 30 days
measure: Postoperative sepsis
timeFrame: 30 days
measure: Risk score calculation: Euroscore II
timeFrame: 30 days
measure: Length of stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Paris
country: France
facility: département de cardiologie et d'anesthésie réanimation Hôpital Bichat 46 rue Henri Huchard
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Bernard IUNG, MD.
role: STUDY_DIRECTOR
References: