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

NCT07307729 | Not Yet Recruiting

• 1 other identifier: B202505066
• Study Type: interventional
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hyperkalaemia

Keywords

artificial intelligence; electrocardiogram; emergency department; hyperkalemia; potassium; treatment

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  All-cause mortality

  90 days

Study Arms (2)

Timely treatment

EXPERIMENTAL

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

Behavioral: Timely treatment

Delayed treatment

EXPERIMENTAL

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

Behavioral: Delayed treatment

Interventions

Timely treatment BEHAVIORAL

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

Also known as: Timely treatment of potassium-lowering treatment

Timely treatment

Delayed treatment BEHAVIORAL

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

Delayed treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead

MeSH Terms

Conditions

Hyperkalemia; Emergencies

Interventions

Treatment Delay

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Time-to-Treatment; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Retrospective studies are not applicable.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: January 1, 2026
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share