Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:41 AM
Study NCT ID:
NCT06901960
Status:
RECRUITING
Last Update Posted:
2025-09-17
First Post:
2025-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monitoring Hyperkalemia Using Point-of-care AI-enabled ECG Device Among Patients With Chronic Kidney Disease Stages 3b-5
Sponsor:
Peking University First Hospital
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POCKET
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: