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

NCT ID: NCT06901960

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1066 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-02
• Study Completion Date: 2026-12-31

Brief 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

Conditions

Chronic Kidney Disease (Stages 3b-5)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Monitoring plasma potassium using ECG device

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.

Group Type: EXPERIMENTAL

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)

Intervention Type: 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.

Regular outpatients follow-up

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Site Status: NOT_YET_RECRUITING

Hubei Provincial Hospital of TCM

Wuhan, Hubei, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Jinwei Wang, Ph.D.

Role: CONTACT

wangjinwei@bjmu.edu.cn

+86-010-83572388

Facility Contacts

Jinwei Wang, Ph.D.

Role: primary

wangjinwei@bjmu.edu.cn

+86-010-83572388

Ling Pan, M.D.

Role: primary

nnpanling008@sina.com

+86-0771-5356533

Xue Xue, M.D.

Role: primary

2672754432@qq.com

+86-027-88710029

Other Identifiers

2024-943

Identifier Type: -

Identifier Source: org_study_id