Postoperative Morbidity and Mortality After Cardiac Surgery

Cardiac Surgery Under Extra Corporeal Circulation Clinical Trial

— Cardiobase  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03393169
• Other study ID #: Cardiobase
• Status: Recruiting
• Phase: N/A
• First received: May 2, 2017
• Last updated: January 2, 2018
• Start date: January 1, 2006
• Est. completion date: June 2027

Study information

• Verified date: December 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Bernard IUNG, MD.
• Phone: 01 40 25 66 01
• Email: bernard.Iung[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 12000
• Est. completion date: June 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Cardiac Surgery Under Extra Corporeal Circulation

Locations

Country	Name	City	State
France	département de cardiologie et d'anesthésie réanimation Hôpital Bichat 46 rue Henri Huchard	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	All-cause mortality is assessed during in-hospital stay and 30 days after the date of surgery	30 days
Secondary	Postoperative organ failure	Cardiac with inotropic or mechanical support, renal failure or need for dialysis, pulmonary (mechanical ventilation duration), neurologic or digestive complications	30 days
Secondary	Bleeding complications	Total blood loss, transfusion requirements, surgical reexploration	30 days
Secondary	Arrhythmias	Atrial fibrillation, ventricular tachycardia	30 days
Secondary	Conductions disturbances	Need for pace maker implantation	30 days
Secondary	Myocardial injury	Troponin I release (ng/mL)	30 days
Secondary	Postoperative sepsis	Pneumonia, septicemia and endocarditis, surgical site infection	30 days
Secondary	Risk score calculation: Euroscore II	Calculation with all the items required by the published and validated equation	30 days
Secondary	Length of stay	Length of stay in ICU	30 days