Monitoring Hyperkalemia Using Point-of-care AI-enabled ECG Device Among Patients With Chronic Kidney Disease Stages 3b-5 to Reduce Rate of Hyperkalemia - a Practical Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,066
- 试验地点
- 3
- 主要终点
- Incidence of serum potassium ≥ 5.0 mmol/L
研究概览
简要总结
The clinical trial will be conducted in a real-world outpatients setting with the goal of learning if monitoring serum potassium frequently among patients with moderate-to-advanced stages of chronic kidney disease leading to optimal management of hyperkalemia (the reduced occurrence of serum potassium ≥ 5.0 mmol/L during 6 months of follow-up). It will also learn about the adherence of using a mobile monitoring device.
Participants will:
- Measure their serum potassium using an AI-enhanced point-of-care ECG device at least twice per week
- Receive health education prompts to reduce intake of potassium rich foods if their electrocardiogram device measured serum potassium is abnormal
- Receive alerts to visit nephrology clinic if their electrocardiogram device measured serum potassium is continuously abnormal
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic kidney disease stages 3b-5 (eGFR: 10 - <45 ml/min/1.73m²)
- •Patients with regular visits in the study sites to manage their chronic kidney disease (≥ 1 visit per 3 months during the past year before enrollment)
- •Willingness to participate in the study with signed informed consent
排除标准
- •Patients already under kidney replacement therapy or will receive kidney replacement therapy in 6 months
- •Unwillingness or without the ability to monitor hyperkalemia using the study device
- •Patients with heart pacemaker implanted
研究组 & 干预措施
Monitoring plasma potassium using ECG device
Patients in this arm will use AI-enhanced point-of-care ECG device to monitor their serum potassium level every 3 days for 6 months in addition to their regular outpatients follow-up. If ECG device detected hyperkalemia was reported, more intensive monitoring, education on diet or offer of making outpatient appointment, as appropriate, will be provided.
干预措施: A mobile artificial intelligence-enhanced electrocardiogram device estimating plasma potassium categories (<5 mmol/L, 5 - <5.5 mmol/L, 5.5 - <6.0 mmol/L and ≥ 6.0 mmol/L) (Device)
Regular outpatients follow-up
Patients in this arm will just follow their regular outpatients care without additional intervention.
结局指标
主要结局
Incidence of serum potassium ≥ 5.0 mmol/L
时间窗: Six months (+1 month if outpatients visit delayed) after enrollment into the study
The serum potassium should be the laboratory measured one, which is obtained in the 3(±1) month and 6(±1) month follow-up in outpatients visit.
次要结局
- Average level of serum potassium(Six month (+1 month if outpatients visit delayed) after enrollment into the study)
- Frequency of using AI-enhanced ECG device to monitor serum potassium(Six months (+1 month if outpatients visit delayed) after enrollment into the study and 3 months (+1 month if outpatients visit delayed) after the 6 months of intervention.)