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

Kyungho Park

Status: Not yet enrolling

Conditions: Chronic Kidney Disease; Hyperkalemia

Treatments: Device: HiCardi wearable ECG

Study type: Observational

Funder types: Other

Identifiers

NCT07054905

CNUH 2025-05-023

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Hemodialysis Patients

Description:

Adults with chronic kidney disease receiving maintenance hemodialysis three times per week. Participants will wear a HiCardi single-lead wearable ECG device during dialysis sessions for 8 weeks. ECG data will be collected four times in coordination with routine blood potassium tests to evaluate the correlation between ECG waveform changes and hyperkalemia.

Treatment:

Device: HiCardi wearable ECG