Prediction of Hyperkalemia in Dialysis Patients Through Waveform Analysis Using Wearable ECG
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Correlation between EKG characteristics and serum potassium level
研究概览
简要总结
This study aims to evaluate whether hyperkalemia, a potentially life-threatening condition in dialysis patients, can be detected early using a wearable single-lead ECG device. Patients with chronic kidney disease undergoing hemodialysis will wear a chest-attached ECG sensor (HiCardi) during dialysis sessions. ECG data will be collected four times over six weeks, in coordination with routine blood tests measuring serum potassium levels. The goal is to analyze changes in ECG waveforms, such as T waves, and determine if these correlate with elevated potassium levels. The study is non-interventional and observational, focusing on real-time, non-invasive monitoring. It is expected to improve clinical decision-making by enabling early detection of hyperkalemia without additional blood tests.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older
- •Diagnosed with chronic kidney disease (CKD) and receiving maintenance hemodialysis three times per week
- •Stable clinical condition without acute complications in the past 3 months
- •Ability to understand and sign informed consent
- •No physical or physiological barrier to wearing an ECG device
排除标准
- •Significant skin conditions (e.g., severe dermatitis, burns) that prevent ECG device attachment
- •Refusal or inability to comply with study procedures
结局指标
主要结局
Correlation between EKG characteristics and serum potassium level
时间窗: Week 0, Week 2, Week 4, Week 6
The primary outcome is the correlation between EKG characteristics (e.g., T wave amplitude, QRS duration, P wave morphology) measured using a wearable single-lead ECG device and serum potassium levels obtained from blood tests. Data will be collected at four time points over 8 weeks.
次要结局
未报告次要终点
研究者
Kyungho Park
Assistant Professor of Nephrology, Chungnam National University Hospital
Chungnam National University Hospital