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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorPeking University First Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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)

    Device

    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.

Treatment groups

1,066 Participants
are divided into 2 treatment groups
Group A: Monitoring plasma potassium using ECG deviceExperimental treatment 1 intervention
Group B: Regular outpatients follow-upNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Incidence of serum potassium ≥ 5.0 mmol/L

The serum potassium should be the laboratory measured one, which is obtained in the 3(±1) month and 6(±1) month follow-up in outpatients visit.

Time frame
Six months (+1 month if outpatients visit delayed) after enrollment into the study

Secondary outcomes

1

Average level of serum potassium

The serum potassium should be the laboratory measured one, which is obtained in the 3(±1) month and 6(±1) month follow-up in outpatients visit.

Time frame
Six month (+1 month if outpatients visit delayed) after enrollment into the study
2

Frequency of using AI-enhanced ECG device to monitor serum potassium

The frequency will be monitored in intervention period for the intervention group and after intervention (up to 4 months) for both the original intervention and control groups.

Time frame
Six months (+1 month if outpatients visit delayed) after enrollment into the study and 3 months (+1 month if outpatients visit delayed) after the 6 months of intervention.

Other outcomes

1

Incidence of serum potassium ≥ 5.0 mmol/L after the intervention period

We collect incidence of serum potassium ≥ 5.0 mmol/L after the intervention period to see whether there is still a gap between the original intervention and control groups with the latter one having obtained the device.

Time frame
Three months (+1 month if outpatients visit delayed) after the 6 months of intervention

Sponsors and contacts

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