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

Peking University

Status: Enrolling

Conditions: Chronic Kidney Disease (Stages 3b-5)

Treatments: Device: 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)

Study type: Interventional

Funder types: Other

Identifiers

NCT06901960

2024-943

Details and patient eligibility

About

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

Enrollment: 1,066 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,066 participants in 2 patient groups

Monitoring plasma potassium using ECG device

Experimental group

Description:

Patients in this arm will use AI-enhanced point-of-care ECG device to monitor their serum potassium level every 3 days for 6 months in addition to their regular outpatients follow-up. If ECG device detected hyperkalemia was reported, more intensive monitoring, education on diet or offer of making outpatient appointment, as appropriate, will be provided.

Treatment:

Device: 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)

Regular outpatients follow-up

No Intervention group

Description:

Patients in this arm will just follow their regular outpatients care without additional intervention.