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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Hyperkalemia Chronic Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hemodialysis Patients

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.

HiCardi wearable ECG

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No