PREdiCtIon of Weanability, Survival and Functional outcomEs After ECLS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 800
- 试验地点
- 6
- 主要终点
- Mortality
研究概览
简要总结
Extracorporeal life support (ECLS) is used as a last resort intervention in patients with severe cardiac, circulatory and/or respiratory failure with high (>80%) expected mortality. Despite considerable improvements in patient selection and outcomes, mortality and morbidity after ECLS remain high. An improved selection and management of patients who are supported with ECLS is therefore unquestionably needed from a perspective of optimal patient care and the socio-economic impact of this costly intervention.
详细描述
This observational multicenter study was designed to serve the following objectives:
- Develop a (dynamic) prediction tool for survival and quality of life outcomes 1 year after ECLS support for the situation at baseline and 7 days after ECLS initiation
- Study the association between application of left ventricular unloading and ECLS support duration and weanability
- Description of the incidence of VA ECLS weaning failure and identification of predictors for VA ECLS weaning failure
Under this umbrella research protocol, the data collected by this observational multicenter study can also be reused for potential novel substudies with the objective to improve the quality of care and the efficiency of current treatment strategies involving ECLS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having received (VA and/or VV) ECLS
- •All ECLS indications (refractory cardiac, circulatory and/or respiratory failure)
- •Surgical and medical patients
排除标准
- •< 18 years of age
- •ECLS confined to cardiac surgery in the operating room (OR) or in the catheterization laboratory
- •Objection against use of clinical data (opt-out principle)
结局指标
主要结局
Mortality
时间窗: In-hospital mortality up to 30 days and through study completion, an average of 1 year.
Weaning success
时间窗: In-hospital up to 30 days
30 day survival without left ventricular assist device, heart transplantation or short Term mechanical support
QoL
时间窗: 1 year after admission
By the EuroQol EQ-5D, an instrument to measure health related quality of life. It assesses health in five domains; mobility, self-care, usual activities, pain/discomfort and anxiety/depression, ranging from 1 to 3 in each domain (e.g. from 1 'I am not anxious or depressed' to 3 'I am extremely anxious or depressed' in the anxiety/depression domain) finding 243 unique health states. These health states can be converted into an index ranging from 0 (death) to 1 (perfect health)
次要结局
- ICU admission length of stay(ICU days up to 30 days and 1 year)
- Complications(During ECLS support up to 30 days and 1 year)
- ECLS support duration(ECLS days up to 30 days and 1 year)
- 30 day mortality(30 days)
- 60 day mortality(60 days)