A Pilot Study Assessing the Feasibility and Effectiveness of a Perioperative Multi-component Intervention in Patients With Acute Decompensated Aortic Stenosis Undergoing Urgent Transcatheter Aortic Valve Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility: Safety
研究概览
简要总结
This is a pilot randomised control study assessing the feasibility and effectiveness of a perioperative multi-component intervention aimed at reducing adverse hospital events and improving functional outcomes in patients with acute decompensated aortic stenosis undergoing urgent transcatheter aortic valve implantation compared to standard care.
The intervention will consist of physical rehabilitation, delirium prevention, nutritional supplementation and anaemia correction (where indicated). The primary objective is to determine the feasibility and safety of delivering this intervention Secondary objectives include investigating the impact on adverse hospital events such as hospital-acquired disability and post-TAVI delirium, and on health-related quality of life and functional recovery following TAVI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 70 years
- •Ability to provide written informed consent
- •Ability to speak English
- •Exclusion criteria:
- •Clinical instability defined as requiring use of inotropes/mechanical-circulatory support during admission or post-cardiac arrest
- •Active delirium (4AT score ≥ 4) at time of recruitment
- •Parkinson's disease (Hoehn & Yahr stage 3-5)
- •Recent stroke (within 7 days preceding recruitment)
- •Terminal condition (e.g. metastatic cancer) with life expectancy < 12 months
- •Clinical unsuitable for recruitment to trial according to the discretion of the research team
排除标准
- 未提供
研究组 & 干预措施
Control
Routine inpatient care
Intervention
Perioperative multi-component intervention
干预措施: Perioperative multi-component intervention (Other)
结局指标
主要结局
Feasibility: Safety
时间窗: On discharge: e.g. 2-7 days
In-hospital adverse events (e.g. falls, ischaemia, arrhythmia, acute kidney injury), in-hospital mortality
Feasibility: Recruitment rates
时间窗: 1 year
Average number of patients per month willing to give informed consent and be randomised into a trial of a perioperative frailty intervention
次要结局
- Change in cognitive function(30 days)
- Incidence of hospital-acquired disability(30 days)
- Incidence of delirium(Daily (during inpatient admission) until the seventh day post-TAVI and then twice weekly thereafter)
- Changes in health-related quality of life(30 days)
- Change in mood(30 days)
- Incidence of falls during hospitalisation(On discharge: e.g. 2-7 days)
- Length of hospital stay(On discharge: e.g. 2-7 days)
- Discharge destination(On discharge: e.g. 2-7 days)
- Unplanned readmissions(30 days)
- Mortality(30 days)
- Changes in physical frailty(On discharge: e.g. 2-7 days)