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Smart patch could spot silent killer in kidney patients without needles

NCT ID NCT07054905

Diagnosis Sponsor: Kyungho Park Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a small, chest-worn ECG device can detect high potassium levels (hyperkalemia) in people with chronic kidney disease undergoing dialysis. Thirty-two patients wore the device during dialysis sessions, and the ECG readings were compared with blood test results. The goal is to find a non-invasive way to spot dangerous potassium spikes early, potentially reducing the need for frequent blood draws and improving patient safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HiCardi wearable ECG device
What this could lead to
If successful, this could lead to a non-invasive way to monitor potassium levels in dialysis patients, reducing the need for frequent blood draws and enabling earlier intervention.
What could go wrong
This is a small, completed observational study with only 32 participants. The results may not apply to all dialysis patients, and the device's accuracy needs confirmation in larger trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

32 people

The number who actually took part.

Started

Jun 2025

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with chronic kidney disease undergoing regular hemodialysis at Chungnam National University Hospital. Participants are selected based on clinical stability and willingness to provide informed consent. The population includes both male and female adults without age restriction.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults aged 19 years or older * Diagnosed with chronic kidney disease (CKD) and receiving maintenance hemodialysis three times per week * Stable clinical condition without acute complications in the past 3 months * Ability to understand and sign informed consent * No physical or physiological barrier to wearing an ECG device Exclusion Criteria: * Significant skin conditions (e.g., severe dermatitis, burns) that prevent ECG device attachment * Refusal or inability to comply with study procedures

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome Hyperkalemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease Hyperkalemia

Contacts and locations

Locations

  • Chungnam National University Hospital

    Daejeon, South Korea

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