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

Kyungho Park32 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hyperkalemia Chronic Kidney Disease

Interventions

HiCardi wearable ECGDEVICE

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Correlation between EKG characteristics and serum potassium level

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.

Time frame: Week 0, Week 2, Week 4, Week 6