Monitoring Hyperkalemia Using Point-of-care AI-enabled ECG Device Among Patients With Chronic Kidney Disease Stages 3b-5
Recruiting · NCT06901960 · Interventional (participants receive a specific treatment) · Lead sponsor: Peking University First Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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
Where it is running
3 locations listed.
- Peking University First Hospital - Beijing, Beijing Municipality, China
- The First Affiliated Hospital of Guangxi Medical University - Nanning, Guangxi, China
- Hubei Provincial Hospital of TCM - Wuhan, Hubei, China