Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monitoring plasma potassium using ECG device | Experimental | 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. |
|
| Regular outpatients follow-up | No Intervention | Patients in this arm will just follow their regular outpatients care without additional intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A 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) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serum potassium ≥ 5.0 mmol/L | 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. | Six months (+1 month if outpatients visit delayed) after enrollment into the study |
| Measure | Description | Time Frame |
|---|---|---|
| Average level of serum potassium | 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. | Six month (+1 month if outpatients visit delayed) after enrollment into the study |
| Frequency of using AI-enhanced ECG device to monitor serum potassium |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serum potassium ≥ 5.0 mmol/L after the intervention period | 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. | Three months (+1 month if outpatients visit delayed) after the 6 months of intervention |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinwei Wang, Ph.D. | Contact | +86-010-83572388 | wangjinwei@bjmu.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
IPD used in the results publication will be shared upon reasonable request.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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. |
| 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 First Affiliated Hospital of Guangxi Medical University | Not yet recruiting | Nanning | Guangxi | 530021 | China |
|
| Hubei Provincial Hospital of TCM | Not yet recruiting | Wuhan | Hubei | 430063 | China |
|
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006947 | Hyperkalemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided