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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Peking University First Hospital
RECRUITING
Beijing
The First Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITING
Nanning
Hubei Provincial Hospital of TCM
NOT_YET_RECRUITING
Wuhan
Contact Information
Primary
Jinwei Wang, Ph.D.
wangjinwei@bjmu.edu.cn
+86-010-83572388
Time Frame
Start Date: 2025-04-02
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 1066
Treatments
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.
No_intervention: Regular outpatients follow-up
Patients in this arm will just follow their regular outpatients care without additional intervention.
Related Therapeutic Areas
Sponsors
Leads: Peking University First Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials