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POCKETNCT06901960

Monitoring Hyperkalemia Using Point-of-care AI-enabled ECG Device Among Patients With Chronic Kidney Disease Stages 3b-5

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved 12 months later.

See at-risk trials from Peking University First Hospital

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 31, 2026 to Dec 31, 2027 Show 4 more changesShow less
    • Eligibility criteria expanded, about 6 words
    • Primary endpoints: details revised at 1 of 1 entry
    • Study completion pushed from Dec 31, 2026 to May 31, 2028
    • Interventions: A mobile artificial intelligence-enhanced electrocardiogram device estimating plasma potassium categories (<5 mmol/L, 5 - <5.5 mmol/L, 5.5… to A mobile artificial intelligence-enhanced electrocardiogram device estimating plasma potassium categories (<5 mmol/L, 5 - <5.5 mmol/L, 5.5…
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 8 more changesShow less
    • Enrollment target: 344 to 1066
    • Primary and study completion dates: Jun 30, 2026 to Dec 31, 2026
    • Eligibility criteria revised
    • Primary endpoint revised
    • Interventions: A mobile artificial intelligence-enhanced eletrocardiogram device measuring plasma potassium (Device) to A mobile artificial intelligence-enhanced electrocardiogram device estimating plasma potassium categories (<5 mmol/L, 5 - <5.5 mmol/L, 5.5…
    • Secondary endpoints revised (2)
    • Site details revised at 3 of 3 sites
    • Study title revised
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Incidence of serum potassium ≥ 5.0 mmol/L
Timeframe: Six months (+1 month if outpatients visit delayed) after enrollment into the study

Secondary (2)

Average level of serum potassium
Frequency of using AI-enhanced ECG device to monitor serum potassium

Arms and interventions

Monitoring plasma potassium using ECG deviceExperimental

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-upNo intervention

Patients in this arm will just follow their regular outpatients care without additional intervention.

Devices: 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)

Sites

3 sites in 1 country