CMC Ambroise Paré
Neuilly-sur-Seine, Île-de-France Region, 92200, France
Location status: Recruiting
NCT Number: NCT03209674
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.
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Observational
Neuilly-sur-Seine, Île-de-France Region, 92200, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cardiac or thoracic procedure
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
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
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
Time frame: During follow-up, until discharge from the hospital, up to 1 year.
length of stay in the hospital, including preoperative period
Time frame: During follow-up, until discharge from the hospital, up to 1 year.
Incidence of mediastinitis in the postoperative period
Time frame: During follow-up, until discharge from the hospital, up to 1 year.
Redo surgery after primary surgery
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
Contact information is provided by the study sponsor or research team.
CMC Ambroise Paré
Other
Acronym: RIPOSTE
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.
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