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

NCT06901960 | Recruiting

• 1 other identifier: 2024-943
• Study Type: interventional
• Target: 1,066
• Locations: 1 country
• Sites: 3

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)

Keywords

Chronic kidney disease; hyperkalemia; ECG

Outcome Measures

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.

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

Secondary Outcomes (2)

• Average level of serum potassium

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

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

  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

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

Study Arms (2)

Monitoring plasma potassium using ECG device

EXPERIMENTAL

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.

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

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

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) 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.

Monitoring plasma potassium using ECG device

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (3)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

NOT YET RECRUITING

Hubei Provincial Hospital of TCM

Wuhan, Hubei, 430063, China

NOT YET RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperkalemia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Jinwei Wang, Ph.D.

CONTACT

+86-010-83572388; wangjinwei@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: April 2, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (3)