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 to Reduce Rate of Hyperkalemia - a Practical Randomized Clinical Trial
Peking University First Hospital
1,066 participants
Apr 2, 2025
INTERVENTIONAL
Conditions
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 ≥ 5.0 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 Criteria3
- 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 Criteria3
- 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
Interventions
A mobile AI-enhanced electrocardiogram device will be used to help patients monitor hyperkalemia. The device, shaped like a stick of chewing gum, collects time-series data of electrocardiogram lead I through two electrodes. Deep convolutional neural network algorithm can read the data and generated categories of plasma potassium (\<5 mmol/L, 5 - \<5.5 mmol/L, 5.5 - \<6.0 mmol/L and ≥ 6.0 mmol/L). Study participants receive the device after randomization. The staff establishes a WeChat group for each participant and reminds them to monitor plasma potassium every 3 days. When the detected plasma potassium category falls in 5 - \<5.5 mmol/L, they will be reminded to watch diet and to verify plasma potassium again. More intensive reminding (once daily) will be sent if plasma potassium category falls in 5.5 - \<6.0 mmol/L or ≥ 6.0 mmol/L. An extra outpatient appointment will also be made as soon as possible for the patients when their detected plasma potassium category is ≥ 6.0 mmol/L.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06901960