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

Recruiting

• Conditions: Postoperative Complications; Cardiac Complication; Heart Diseases; Death

• Registration Number: NCT03209674
• Lead Sponsor: CMC Ambroise Paré

Brief Summary

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.

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 Timeline

• Study Start: 2012-01-01
• Study First Submitted: 2017-07-03
• Study First Submitted QC: 2017-07-04
• Study First Posted: 2017-07-06
• Status Verified: 2023-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-10
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8000

Inclusion Criteria

• all patients eligible for cardiac or thoracic surgery

Exclusion Criteria

• non applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In-hospital mortality	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

Secondary Outcome Measures

Name	Time	Method
Total length of stay (days)	During follow-up, until discharge from the hospital, up to 1 year.	length of stay in the hospital, including preoperative period
Mediastinitis	During follow-up, until discharge from the hospital, up to 1 year.	Incidence of mediastinitis in the postoperative period
Pneumoniae	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
Postoperative shock	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
Length of stay in the ICU (days)	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
Redo surgery	During follow-up, until discharge from the hospital, up to 1 year.	Redo surgery after primary surgery

Trial Locations

Locations (1)

CMC Ambroise Paré; 🇫🇷 Neuilly-sur-Seine, Ile-de-France, France