Postoperative Morbidity and Mortality After Cardiac Surgery (Cardiobase)

January 2, 2018 updated by: Assistance Publique - Hôpitaux de Paris

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75018
        • Recruiting
        • département de cardiologie et d'anesthésie réanimation Hôpital Bichat 46 rue Henri Huchard
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 30 days
All-cause mortality is assessed during in-hospital stay and 30 days after the date of surgery
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
30 days
Bleeding complications
Time Frame: 30 days
Total blood loss, transfusion requirements, surgical reexploration
30 days
Arrhythmias
Time Frame: 30 days
Atrial fibrillation, ventricular tachycardia
30 days
Conductions disturbances
Time Frame: 30 days
Need for pace maker implantation
30 days
Myocardial injury
Time Frame: 30 days
Troponin I release (ng/mL)
30 days
Postoperative sepsis
Time Frame: 30 days
Pneumonia, septicemia and endocarditis, surgical site infection
30 days
Risk score calculation: Euroscore II
Time Frame: 30 days
Calculation with all the items required by the published and validated equation
30 days
Length of stay
Time Frame: 30 days
Length of stay in ICU
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bernard IUNG, MD., Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2006

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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