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Clinical Trials/NCT03393169
NCT03393169
Recruiting
Not Applicable

Evaluation of Post-operative Morbidity and Mortality After Cardiac Surgery Performed in Bichat Hospital

Assistance Publique - Hôpitaux de Paris1 site in 1 country12,000 target enrollmentJanuary 1, 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Surgery Under Extra Corporeal Circulation
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
12000
Locations
1
Primary Endpoint
All-cause mortality
Status
Recruiting
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2006
End Date
June 2027
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

  • Not provided

Outcomes

Primary Outcomes

All-cause mortality

Time Frame: 30 days

All-cause mortality is assessed during in-hospital stay and 30 days after the date of surgery

Secondary Outcomes

  • Postoperative organ failure(30 days)
  • Bleeding complications(30 days)
  • Arrhythmias(30 days)
  • Conductions disturbances(30 days)
  • Myocardial injury(30 days)
  • Postoperative sepsis(30 days)
  • Risk score calculation: Euroscore II(30 days)
  • Length of stay(30 days)

Study Sites (1)

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