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.

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Key information

Conditions

Hyperkalemia Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Water-Electrolyte Imbalance

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chungnam National University Hospital

Daejeon, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HiCardi wearable ECG

Device

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.

Primary outcomes

Correlation between EKG characteristics and serum potassium level

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

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.

Sponsors and collaborators

Lead sponsor

Kyungho Park

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jul 8, 2025
Registry last updated: Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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