An interventional study of 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) in Chronic Kidney Disease (Stages 3b-5), sponsored by Peking University First Hospital. Recruiting at 3 sites in China. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-09-17.
Sponsored by Peking University First Hospital · Not applicable, Interventional, and Prevention
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:
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's planned enrollment of 1,066 is above the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Peking University First Hospital is the lead sponsor of 390 studies on the registry; 186 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: 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)
Patients in this arm will just follow their regular outpatients care without additional intervention.
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.
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.
Time frame: Six months (+1 month if outpatients visit delayed) after enrollment into the study
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.
Time frame: Six month (+1 month if outpatients visit delayed) after enrollment into the study
Frequency of using AI-enhanced ECG device to monitor serum potassium
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.
Time frame: 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.
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.
Time frame: Three months (+1 month if outpatients visit delayed) after the 6 months of intervention
Plan to share: Yes — IPD used in the results publication will be shared upon reasonable request.
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