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

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.

NCT Number	NCT07054905
Lead Sponsor	Kyungho Park
Conditions	Hyperkalemia, Chronic Kidney Disease
Enrollment	32 participants
Start Date	2025-06-23
Primary Completion	2025-08-28 (estimated)
Study Completion	2025-08-28 (estimated)
Updated on ClinicalTrials.gov	2026-03-20