Chronic Kidney Disease (Stages 3b-5)
Conditions
Keywords
Chronic kidney disease, hyperkalemia, ECG
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
Interventions
DEVICEA 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.
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of serum potassium ≥ 5.0 mmol/L | Six months (+1 month if outpatients visit delayed) after enrollment into the study | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average level of serum potassium | Six month (+1 month if outpatients visit delayed) after enrollment into the study | 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. |
| Frequency of using AI-enhanced ECG device to monitor serum potassium | 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. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of serum potassium ≥ 5.0 mmol/L after the intervention period | Three months (+1 month if outpatients visit delayed) after the 6 months of intervention | 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. |
Countries
China
Contacts
Primary ContactJinwei Wang, Ph.D.
Outcome results
None listed