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

RecruitingNAAges 18 Years - 99 YearsAllPeking University First Hospital
NCT06901960 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • A mobile artificial intelligence-enhanced electrocardiogram device estimating plasma potassium categories (<5 mmol/L, 5 - <5.5 mmol/L, 5.5 - <6.0 mmol/L and ≥ 6.0 mmol/L)
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Where

3 sites
Peking University First Hospital
Beijing, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
Hubei Provincial Hospital of TCM
Wuhan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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