NCT05118022

Brief Summary

This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of potassium abnormalities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14,989

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 11, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

November 1, 2021

Last Update Submit

September 13, 2024

Conditions

HyperkalemiaHypokalemia

Outcome Measures

Primary Outcomes (2)

  • Cumulative proportion of hyperkalemia treatment

    Calcium supplement, insulin, potassium binding resin, β2-agonist, loop diuretics, sodium bicarbonate, and hemodialysis.

    Within 3 hours

  • Cumulative proportion of hypokalemia treatment

    Intravenous potassium chloride, oral potassium gluconate, and oral potassium chloride

    Within 3 hours

Secondary Outcomes (7)

  • Cardiac arrest (sudden death)

    Within 3 days

  • Cumulative proportion of All-cause mortality

    Within 365 days

  • Cumulative proportion of electric shock

    Within 6 hours

  • Cumulative proportion of CPR event

    Within 6 hours

  • Cumulative proportion of Discharge

    Within 14 days

  • +2 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Patients randomized to intervention will be cared by physicians under AI-ECG support.

Other: Artificial Intelligence identified Dyskalemia using Electrocardiogram (AIDE) system

Control

NO INTERVENTION

Patients randomized to control will be cared by routine practice.

Interventions

Artificial Intelligence identified Dyskalemia using Electrocardiogram (AIDE) systemOTHER

Once the AIDE indicates high risk of dyskalemia, an obvious message by scarlet letter was appeared in the HIS operation interface to corresponding physicians. To avoid the alert fatigue, we selected the cut-off points with expected positive predictive values of ≥40% according to previous data, which was the consensus of enrolled physicians before the trial considering the clinical loading. The physicians received the AIDE alerts as long as they were operating HIS logged in by their account, even if they were caring other patients. Physicians can review the AIDE predictions of patients in the intervention group. Therefore, this was a single-blind study since HIS presented different information for patients in intervention and control groups. The participated physicians understood the likelihood of dyskalemia and cardiac risk for those patients with ECG-dyskalemia, and provided suitable medical care according to patients' conditions.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients in emergency department.
  • Patients recieved at least 1 ECG examination.

You may not qualify if:

  • Patients recieved dyskalemia-related treatment before ECG examination.
  • The patients recieved ECG at the period of inactive AI-ECG system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Defense Medical Center

Taipei, 114, Taiwan

Location

Related Publications (1)

  • Lin C, Lin CS, Chen SJ, Tsai SH, Sung CC, Chen CC, Hsu YJ, Hung YJ, Lin SH. AI-enabled electrocardiogram alert for potassium imbalance treatment: a pragmatic randomized controlled trial. Nat Commun. 2026 Jan 8;17(1):159. doi: 10.1038/s41467-025-66394-4.

    PMID: 41507124DERIVED

MeSH Terms

Conditions

HyperkalemiaHypokalemia

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 1, 2021

First Posted

November 11, 2021

Study Start

January 1, 2022

Primary Completion

October 31, 2022

Study Completion

February 28, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)