Registry for the Improvement of Postoperative OutcomeS in Cardiac and Thoracic surgEry (RIPOSTE)

January 9, 2024 updated by: CMC Ambroise Paré
The registry for the improvement of postoperative outcomes in cardiac and thoracic surgery aims to prospectively collect data in order to test the association between various preoperative and per-operative variables ; and several postoperative outcomes such as mortality, shock, redo surgery, sepsis and extracorporeal life-support.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cardiac and thoracic surgery is plagued by severe morbidity and mortality. Understanding and being able to predict postoperative outcomes may allow to better fit peri-operative care of cardio-thoracic patients.

RIPOSTE database aims to prospectively collect baseline characteristics and per-operative information in order to test associations with the incidence of postoperative outcomes.

Baseline characteristics include: age, EuroSCORE 2 and its components (age, gender, New York Heart Association (NYHA) functional class, angina symptoms, insulin-dependent diabetes mellitus, extracardiac arteriopathy, chronic pulmonary dysfunction, neurological or musculoskeletal dysfunction severely affecting mobility, previous cardiac surgery, renal function with creatinin clearance, active endocarditis, critical preoperative state, left ventricle ejection fraction, recent myocardial infarction, pulmonary artery systolic pressure, procedure urgency and weight of the procedure (coronary artery bypass graft, valve surgery and/or thoracic aorta)) weight, height, preoperative biology and preoperative echocardiography parameters when measured.

Peroperative information include: cardiac bypass duration, type of procedure, implanted device, valve size.

Postoperative outcomes include: death, postoperative shock, mediastinitis, length of stay in intensive care unit, overall length of stay, blood transfusion.

Study Type

Observational

Enrollment (Estimated)

8000

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 Backup

Study Locations

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing cardiac or thoracic surgery in CMC Ambroise Paré

Description

Inclusion Criteria:

  • all patients eligible for cardiac or thoracic surgery

Exclusion Criteria:

  • non applicable

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital mortality
Time Frame: During follow-up, until discharge from hospital, up to 1 year.
death occurring in the same hospital where the operation took place before discharge from the hospital
During follow-up, until discharge from hospital, up to 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative shock
Time Frame: In the first 24 hours after surgery
Use of catecholamines (dobutamine, norepinephrine and/or epinephrine) in order to achieve adequate cardiac output (cardiac index > 2.2 l/min/m2), in the first 24 hours after surgery
In the first 24 hours after surgery
Length of stay in the ICU (days)
Time Frame: During follow-up, until discharge from the ICU, up to 1 year.
length of stay in the intensive care unit after cardiac or thoracic surgery
During follow-up, until discharge from the ICU, up to 1 year.
Total length of stay (days)
Time Frame: During follow-up, until discharge from the hospital, up to 1 year.
length of stay in the hospital, including preoperative period
During follow-up, until discharge from the hospital, up to 1 year.
Mediastinitis
Time Frame: During follow-up, until discharge from the hospital, up to 1 year.
Incidence of mediastinitis in the postoperative period
During follow-up, until discharge from the hospital, up to 1 year.
Redo surgery
Time Frame: During follow-up, until discharge from the hospital, up to 1 year.
Redo surgery after primary surgery
During follow-up, until discharge from the hospital, up to 1 year.
Pneumoniae
Time Frame: During follow-up, until discharge from the hospital, up to 1 year.
Hospital-acquired or Ventilator-acquired pneumonia as defined by Center for Disease Control guidelines
During follow-up, until discharge from the hospital, up to 1 year.

Collaborators and Investigators

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

Sponsor

CMC Ambroise Paré

Investigators

  • Study Chair: Marie-Caroline Merand, CMC Ambroise Paré

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2012

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 3, 2017

First Submitted That Met QC Criteria

July 4, 2017

First Posted (Actual)

July 6, 2017

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIPOSTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

non-applicable.

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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