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临床试验/NCT03393169
NCT03393169招募中不适用

Evaluation of Post-operative Morbidity and Mortality After Cardiac Surgery Performed in Bichat Hospital

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 12,000 人开始时间: 2006年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
12,000
试验地点
1
主要终点
All-cause mortality

研究概览

简要总结

The local database results from a joint initiative of anesthesic, cardiology and cardiac surgery departements.Its purpose is to record in an exhaustive fashion all the interventions of cardiac surgery performed under extracorporeal circulation in adults at Bichat hospital.This database includes the preoperative characteristics of the patients, the type of surgery, the post-operative complications and the in-hospital mortality. The purpose of this observational study is to evaluate in-hospital morbidity and mortality for all types of cardiac surgery interventions and to analyze it according to the characteristics of the patients and the type of intervention.

详细描述

The operative mortality is a key point of the risk-to-benefit ratio analysis before considering cardiac surgery. Operative risk evaluation in a single surgical center is a part of medical care quality assessment. It must be interpreted in the light of the local specificities, in particular the characteristics of the patients and the types of surgery. The local database results from a joint initiative of anesthesic, cardiology and cardiac surgery departements.Its purpose is to record in an exhaustive fashion all the interventions of cardiac surgery performed under extracorporeal circulation in adults at Bichat hospital.This database includes the preoperative characteristics of the patients, the type of surgery, the post-operative complications and the in-hospital mortality. The purpose of this observational study is to evaluate in-hospital morbidity and mortality according to the characteristics of the patients and the type of intervention. study population : inclusion criteria : patient 18 years or older with legal capacity, patients with non-objection to record his/her medical data during hospitalization. Methods: this is an observational prospective and monocentric study. The main objective is to report in-hospital mortality for all types of cardiac surgery performed in Bichat hospital . The secondary objectives are :1) to collect post-operative complications such as hemorrhagic or thromboembolic events or surgery site infections; 2) to analyze mortality rate and post-operative morbidities according to the type of surgery and the main patients' characteristics . 3) to calculate validated and currents risk score such as EuroSCORE I and II for each patient.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years and older and has legal capacity - cardiac surgery under extra corporeal circulation
  • non objection to record medical information during hospitalization

排除标准

  • 未提供

结局指标

主要结局

All-cause mortality

时间窗: 30 days

All-cause mortality is assessed during in-hospital stay and 30 days after the date of surgery

次要结局

  • Postoperative organ failure(30 days)
  • Bleeding complications(30 days)
  • Arrhythmias(30 days)
  • Conductions disturbances(30 days)
  • Myocardial injury(30 days)
  • Postoperative sepsis(30 days)
  • Risk score calculation: Euroscore II(30 days)
  • Length of stay(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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