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

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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease (Stages 3b-5)
• Intervention / 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)

• Study Type: Interventional
• Enrollment (Estimated): 1066
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jinwei Wang, Ph.D.; Phone Number: +86-010-83572388; Email: wangjinwei@bjmu.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100034
      • Recruiting
      • Peking University First Hospital
      • Contact: Jinwei Wang, Ph.D.; Phone Number: +86-010-83572388; Email: wangjinwei@bjmu.edu.cn
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Not yet recruiting
      • The First Affiliated Hospital of Guangxi Medical University
      • Contact: Ling Pan, M.D.; Phone Number: +86-0771-5356533; Email: nnpanling008@sina.com
  • Hubei
    • Wuhan, Hubei, China, 430063
      • Not yet recruiting
      • Hubei Provincial Hospital of TCM
      • Contact: Xue Xue, M.D.; Phone Number: +86-027-88710029; Email: 2672754432@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Regular outpatients follow-up; Patients in this arm will just follow their regular outpatients care without additional intervention.
Experimental: 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.	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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Six month (+1 month if outpatients visit delayed) after enrollment into the study
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Three months (+1 month if outpatients visit delayed) after the 6 months of intervention

Collaborators and Investigators

• Sponsor: Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Chronic kidney disease; hyperkalemia; ECG
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Renal Insufficiency; Water-Electrolyte Imbalance; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Renal Insufficiency, Chronic; Hyperkalemia
• Other Study ID Numbers: 2024-943

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD used in the results publication will be shared upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No