Registry for the Improvement of Postoperative OutcomeS in Cardiac and Thoracic surgEry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 8,000
- 试验地点
- 2
- 主要终点
- In-hospital mortality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients eligible for cardiac or thoracic surgery
排除标准
- •non applicable
结局指标
主要结局
In-hospital mortality
时间窗: 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
次要结局
- Pneumoniae(During follow-up, until discharge from the hospital, up to 1 year.)
- Total length of stay (days)(During follow-up, until discharge from the hospital, up to 1 year.)
- Mediastinitis(During follow-up, until discharge from the hospital, up to 1 year.)
- Postoperative shock(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.)
- Redo surgery(During follow-up, until discharge from the hospital, up to 1 year.)