CompletedNot Applicable

Prediction of Hyperkalemia in Dialysis Patients Through Waveform Analysis Using Wearable ECG

South Korea32 participantsStarted 2025-06-23

Plain-language 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.

Who can participate

Age range19 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Correlation between EKG characteristics and serum potassium level

Timeframe: Week 0, Week 2, Week 4, Week 6

Trial details

NCT IDNCT07054905

SponsorKyungho Park

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-08-28

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