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临床试验/NCT03913299
NCT03913299进行中(未招募)不适用

Frailty Assessment by Edmonton Frail Scale to Predict Outcome in Patients Undergoing Cardiovascular Surgery "Frail Heart" Study.

Cliniques universitaires Saint-Luc- Université Catholique de Louvain3 个研究点 分布在 1 个国家目标入组 2,080 人开始时间: 2019年4月23日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
2,080
试验地点
3
主要终点
Mortality

研究概览

简要总结

The aim of the study is to assess frailty of patients admited for cardio-vascular surgery in Cliniques Universitaires Saint Luc in Brussels. And analyse the correlation between frailty, functionnal decline and postoperative mortality.

详细描述

Frailty is a state of loss of functional reserve resulting in an increased vulnerability to a stressor event. From a pathophysiological point of view, it is an accelerated decrease in physiological reserve related to ageing.

Currently, evaluation of the outcome after cardiac surgery is commonly based on scores not taking into account the concept of frailty (Society of Thoracic Surgeons (STS) and Eurosore II) Recent studies have shown an independent association between post cardiac surgery mortality and pre-operative frailty. Beyond cardiac surgery, frailty has been shown to be associated with higher mortality and morbidity among intensive care unit (ICU) patients. Frailty is commonly assessed for patients older than 75 years of age but the prevalence in younger patients admitted to the hospital is significant. There is therefore need to evaluate all patients for frailty in the preoperative period.

Since the Edmonton Frail Scale (EFS) allows easy screening of all frailty domains, we hypothesized that it could be a reliable and feasible score to assess preoperative frailty and to predict postoperative morbidity and mortality.

Objectives:

The primary objective of this study is to evaluate preoperative frailty in all adult patients undergoing cardiac and vascular surgery.

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

  • Any cardiac surgery under cardiopulmonary bypass
  • Any vascular surgery

排除标准

  • Salvage surgery
  • Cirrhosis CHILD B or C

结局指标

主要结局

Mortality

时间窗: 1 year

Functionnal decline

时间窗: 1 year

Admission to a nursing home (yes or no) or care dependency (defined by a Katz index higher than 0/6)

次要结局

未报告次要终点

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Sponsor

研究点 (3)

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