Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03393169

Postoperative Morbidity and Mortality After Cardiac 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 for all types of cardiac surgery interventions and to analyze it according to the characteristics of the patients and the type of intervention.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

département de cardiologie et d'anesthésie réanimation Hôpital Bichat 46 rue Henri Huchard

Paris, 75018, France

Location status: Recruiting

Location contact

yolande COSTA

CONTACT

[email protected]

01 40 25 62 48

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. 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

  1. Postoperative organ failure

    Time frame: 30 days

    Cardiac with inotropic or mechanical support, renal failure or need for dialysis, pulmonary (mechanical ventilation duration), neurologic or digestive complications

  2. Bleeding complications

    Time frame: 30 days

    Total blood loss, transfusion requirements, surgical reexploration

  3. Arrhythmias

    Time frame: 30 days

    Atrial fibrillation, ventricular tachycardia

  4. Conductions disturbances

    Time frame: 30 days

    Need for pace maker implantation

  5. Myocardial injury

    Time frame: 30 days

    Troponin I release (ng/mL)

  6. Postoperative sepsis

    Time frame: 30 days

    Pneumonia, septicemia and endocarditis, surgical site infection

  7. Risk score calculation: Euroscore II

    Time frame: 30 days

    Calculation with all the items required by the published and validated equation

  8. Length of stay

    Time frame: 30 days

    Length of stay in ICU

Study contacts

Contact information is provided by the study sponsor or research team.

Bernard IUNG, MD.

CONTACT

[email protected]

01 40 25 66 01

Sophie PROVENCHERE, MD.

CONTACT

[email protected]

01 40 25 51 11

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: Cardiobase

Important dates

Study start
2006
Primary completion
2026
Study completion
2027
First posted
Jan 8, 2018
Registry last updated
Jan 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.