Not Yet RecruitingNot Applicable

AI-Enabled ECG Stratification and Timing of Potassium-Lowering Therapy in Patients With Hyperkalemia: A Target Trial Emulation Study

5,000 participantsStarted 2026-01-01

Plain-language summary

Hyperkalemia is a common and potentially life-threatening electrolyte disorder, yet there is limited evidence guiding the optimal timing of potassium-lowering therapy in routine clinical practice. Although electrocardiographic (ECG) abnormalities are recommended to inform treatment decisions, such findings are often subtle and difficult to recognize consistently by clinicians. This study aims to emulate a target trial to evaluate the association between the timing of potassium-lowering therapy (timely versus delayed initiation) and short-term mortality among patients with laboratory-confirmed hyperkalemia presenting to the emergency department. In addition, the study examines whether artificial intelligence-enabled ECG (AI-ECG) stratification identifies patient subgroups that may differentially benefit from earlier treatment. Using observational electronic health record data from multiple healthcare systems, including publicly available critical care databases and institutionally governed hospital datasets, treatment strategies are compared using causal inference methods designed to approximate randomized assignment. The primary outcome is 90-day all-cause mortality. The results of this study are intended to inform clinical decision-making regarding treatment timing in hyperkalemia and to evaluate the potential role of AI-ECG as a risk stratification tool in real-world settings.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. patients visit to emergency department
. serum potassium ≥5.5 mEq/L
. had a standard 12-lead ECG performed within 1 hour of the qualifying potassium measurement

Exclusion criteria

. potassium-lowering therapy administered before the index blood draw
. no potassium-lowering therapy initiated within 4 hours after the index draw
. duplicate encounters
. missing key covariates

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

All-cause mortality

Timeframe: 90 days

Trial details

NCT IDNCT07307729

SponsorNational Defense Medical Center, Taiwan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-31

View on ClinicalTrials.gov More Hyperkalaemia trials