Postoperative Morbidity and Mortality After Cardiac Surgery (Cardiobase)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery Under Extra Corporeal Circulation

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.

• Study Type: Observational
• Enrollment (Anticipated): 12000

Contacts and Locations

• Study Contact: Name: Bernard IUNG, MD.; Phone Number: 01 40 25 66 01; Email: bernard.Iung@aphp.fr
• Study Contact Backup: Name: Sophie PROVENCHERE, MD.; Phone Number: 01 40 25 51 11; Email: sophie.provenchere@aphp.fr

Study Locations

• France
  • Paris, France, 75018
    • Recruiting
    • département de cardiologie et d'anesthésie réanimation Hôpital Bichat 46 rue Henri Huchard
    • Contact: yolande COSTA; Phone Number: 01 40 25 62 48; Email: yolande.costa@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause mortality is assessed during in-hospital stay and 30 days after the date of surgery	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Bleeding complications	Total blood loss, transfusion requirements, surgical reexploration	30 days
Arrhythmias	Atrial fibrillation, ventricular tachycardia	30 days
Conductions disturbances	Need for pace maker implantation	30 days
Myocardial injury	Troponin I release (ng/mL)	30 days
Postoperative sepsis	Pneumonia, septicemia and endocarditis, surgical site infection	30 days
Risk score calculation: Euroscore II	Calculation with all the items required by the published and validated equation	30 days
Length of stay	Length of stay in ICU	30 days

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Bernard IUNG, MD., Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2006
• Primary Completion (Anticipated): June 1, 2026
• Study Completion (Anticipated): June 1, 2027

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 8, 2018

Study Record Updates

• Last Update Posted (Actual): January 8, 2018
• Last Update Submitted That Met QC Criteria: January 2, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Cardiobase

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: with others French University Hospitals (Rennes, Nantes, Paris (PITIE SALPETRIERE) , Bordeaux)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No