Monitoring Hyperkalemia Using Point-of-care AI-enabled ECG Device Among Patients with Chronic Kidney Disease Stages 3-5

Not Applicable

Not yet recruiting

• Conditions: Chronic Kidney Disease Stages 3-5

• Registration Number: NCT06901960
• Lead Sponsor: Peking University First Hospital

Brief Summary

The clinical trial will be conducted in a real-world outpatients setting with the goal of learning if monitoring serum potassium frequently among patients with moderate-to-advanced stages of chronic kidney disease leading to optimal management of hyperkalemia (the reduced occurrence of serum potassium ≥ 5.5 mmol/L during 1-year follow-up). It will also learn about the adherence of using a mobile monitoring device.

Participants will:

* Measure their serum potassium using an AI-enhanced point-of-care ECG device at least once per week

* Receive health education prompts to reduce intake of potassium rich foods if their eletrocardiogram device measured serum potassium is abnormal

* Receive alerts to visit nephrology clinic if their eletrocardiogram device measured serum potassium is continuously abnormal

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30
• Study Start: 2025-04-02
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 344

Inclusion Criteria

• Patients with chronic kidney disease stages 3-5 (eGFR: 10 - <60 ml/min/1.73m²)
• Patients with regular visits in the study sites to manage their chronic kidney disease (≥ 1 visit per 3 months during the past year before enrollment)
• Willingness to participate in the study with signed informed consent

Exclusion Criteria

• Patients already under kidney replacement therapy or will receive kidney replacement therapy in 6 months
• Unwillingness or without the ability to monitor hyperkalemia using the study device
• Patients with heart pacemaker implantated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
First occurrence of hyperkelamia (plasma potassium ≥ 5.5 mmol/L) within 1 year after recruition	From enrollment to the end of 1 year	Serum potassium is the laboratory-measured value prescribed by physician when the patients visit the nephrology clinic.

Secondary Outcome Measures

Name	Time	Method
First occurrence of hyperkelamia (plasma potassium ≥ 5.5 mmol/L) within 6 month after recruition	From enrollment to the end of 6 months	Serum potassium is the laboratory-measured value prescribed by physicians when patients visit nephrology clinic.
Adherence to the monitoring of hyperkalemia	From enrollment to the end of 1 year	The study paticipants use the AI-enhanced point-of-care ECG device at least 1 time per a week.

Trial Locations

Locations (3)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Guangxi Medical University; 🇨🇳 Nanning, Guangxi, China

Hubei Provincial Hospital of TCM; 🇨🇳 Wuhan, Hubei, China