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NCT Number: NCT06901960

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

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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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of serum potassium ≥ 5.0 mmol/L

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

    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.

Secondary outcomes

  1. Average level of serum potassium

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

    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.

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

    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.

    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.

Other outcomes

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

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jinwei Wang, Ph.D.

CONTACT

[email protected]

+86-010-83572388

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

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

Acronym: POCKET

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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