NCT07054905

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Kyungho Park · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperkalemia
• Chronic Kidney Disease

Interventions

Type	Name	Description
DEVICE	HiCardi 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.

Timeline

• Start date: 2025-06-23
• Primary completion: 2025-08-28
• Completion: 2025-08-28
• First posted: 2025-07-08
• Last updated: 2026-03-20

Locations

1 site across 1 country: South Korea