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

ConditionHyperkalaemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Defense Medical Center, Taiwan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Timely treatment

    Behavioral

    Initiation of any potassium-lowering intervention within 1 hour of the index potassium measurement

  • Delayed treatment

    Behavioral

    Initiation of any potassium-lowering intervention in 1 to 4 hours of the index potassium measurement.

Treatment groups

5,000 Participants
are divided into 2 treatment groups
Group A: Timely treatmentExperimental treatment 1 intervention
Group B: Delayed treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

All-cause mortality

All-cause mortality

Time frame
90 days

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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