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

NCT07054905 | Completed

• 1 other identifier: CNUH 2025-05-023
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Wearable ECG; Hemodialysis; Potassium; HiCardi

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 0, Week 2, Week 4, Week 6

Study Arms (1)

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.

Device: HiCardi wearable ECG

Interventions

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.

Hemodialysis Patients

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic kidney disease undergoing regular hemodialysis at Chungnam National University Hospital. Participants are selected based on clinical stability and willingness to provide informed consent. The population includes both male and female adults without age restriction.

You may qualify if:

• 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

You may not qualify if:

• Significant skin conditions (e.g., severe dermatitis, burns) that prevent ECG device attachment
• Refusal or inability to comply with study procedures

Sponsors & Collaborators

• Kyungho Park: lead

Study Sites (1)

Chungnam National University Hospital

Daejeon, South Korea

Location

MeSH Terms

Conditions

Hyperkalemia; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Nephrology, Chungnam National University Hospital

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: June 23, 2025
• Primary Completion: August 28, 2025
• Study Completion: August 28, 2025
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)