Chronic Kidney Disease, Hyperkalemia
Conditions
Keywords
Wearable ECG, Hemodialysis, Potassium, HiCardi
Brief summary
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.
Interventions
DEVICEHiCardi wearable ECG
A chest-attached, single-lead wearable ECG device used to collect real-time ECG data from hemodialysis patients. The device records ECG waveforms during dialysis sessions and transmits the data to a secure cloud platform. This non-invasive tool is used to analyze T-wave morphology for early detection of hyperkalemia in patients with chronic kidney disease.
Sponsors
Kyungho Park
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Significant skin conditions (e.g., severe dermatitis, burns) that prevent ECG device attachment * Refusal or inability to comply with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between EKG characteristics and serum potassium level | 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. |
Countries
South Korea
Outcome results
None listed