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Postoperative Morbidity and Mortality After Cardiac Surgery

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03393169
Acronym
Cardiobase
Enrollment
12000
Registered
2018-01-08
Start date
2006-01-01
Completion date
2027-06-30
Last updated
2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery Under Extra Corporeal Circulation

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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
All-cause mortality30 daysAll-cause mortality is assessed during in-hospital stay and 30 days after the date of surgery

Secondary

MeasureTime frameDescription
Postoperative organ failure30 daysCardiac with inotropic or mechanical support, renal failure or need for dialysis, pulmonary (mechanical ventilation duration), neurologic or digestive complications
Bleeding complications30 daysTotal blood loss, transfusion requirements, surgical reexploration
Arrhythmias30 daysAtrial fibrillation, ventricular tachycardia
Conductions disturbances30 daysNeed for pace maker implantation
Myocardial injury30 daysTroponin I release (ng/mL)
Postoperative sepsis30 daysPneumonia, septicemia and endocarditis, surgical site infection
Risk score calculation: Euroscore II30 daysCalculation with all the items required by the published and validated equation
Length of stay30 daysLength of stay in ICU

Countries

France

Contacts

Primary ContactBernard IUNG, MD.
bernard.Iung@aphp.fr01 40 25 66 01
Backup ContactSophie PROVENCHERE, MD.
sophie.provenchere@aphp.fr01 40 25 51 11

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026