Registry for the Improvement of Postoperative OutcomeS in Cardiac and Thoracic surgEry (RIPOSTE)
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|ClinicalTrials.gov Identifier: NCT03209674|
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : April 3, 2020
|Condition or disease||Intervention/treatment|
|Heart Diseases Death Postoperative Complications Cardiac Complication||Procedure: Cardiothoracic surgery|
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 [Patient Registry]|
|Estimated Enrollment :||8000 participants|
|Target Follow-Up Duration:||2 Months|
|Official Title:||Registry for the Improvement of Postoperative OutcomeS in Cardiac and Thoracic surgEry|
|Actual Study Start Date :||January 1, 2012|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||December 31, 2025|
- Procedure: Cardiothoracic surgery
Cardiac or thoracic procedure
- 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
- 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
- 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
- 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
- Mediastinitis [ Time Frame: During follow-up, until discharge from the hospital, up to 1 year. ]Incidence of mediastinitis in the postoperative period
- Redo surgery [ Time Frame: During follow-up, until discharge from the hospital, up to 1 year. ]Redo surgery after primary surgery
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209674
|Contact: Alain Brusset, MDfirstname.lastname@example.org|
|Contact: Lee S Nguyen, MDemail@example.com|
|CMC Ambroise Paré||Recruiting|
|Neuilly-sur-Seine, Ile-de-France, France, 92200|
|Contact: Marie-Caroline Merand firstname.lastname@example.org|
|Study Chair:||Marie-Caroline Merand||CMC Ambroise Paré|