NCT06901960Recruiting
Monitoring Hyperkalemia Using Point-of-care AI-enabled ECG Device Among Patients With Chronic Kidney Disease Stages 3b-5
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
Source: ClinicalTrials.gov · Last updated 17 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1066 (estimated)
- First submitted
- 24 Mar 2025
- Start date
- 2 Apr 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Peking University First Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT06901960
What you commit to
- Study type: Interventional
- Planned participants: 1066
- From 2 Apr 2025 to the primary completion date, 31 Dec 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients already under kidney replacement therapy or will receive kidney replacement therapy in 6 months
Other illness
- Patients with heart pacemaker implanted
Other
- Unwillingness or without the ability to monitor hyperkalemia using the study device
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The First Affiliated Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Not yet recruiting |
| Hubei Provincial Hospital of TCM Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.