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

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

Recruiting
18-99 years
All
Phase N/A

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Overview

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 ≥ 5.0 mmol/L during 6 months of 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 twice per week
  • Receive health education prompts to reduce intake of potassium rich foods if their electrocardiogram device measured serum potassium is abnormal
  • Receive alerts to visit nephrology clinic if their electrocardiogram device measured serum potassium is continuously abnormal

Eligibility

Inclusion Criteria:

  • Patients with chronic kidney disease stages 3b-5 (eGFR: 10 - <45 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 implanted

Study details
    Chronic Kidney Disease (Stages 3b-5)

NCT06901960

Peking University First Hospital

15 October 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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