Skip to main content
OpenTrials
Completed

NCT Number: NCT05118022

Artificial Intelligence Identified Dyskalemia Using Electrocardiogram (AIDE)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hyperkalemia Hypokalemia Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Defense Medical Center

Taipei, 114, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Artificial Intelligence identified Dyskalemia using Electrocardiogram (AIDE) system

Other

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.

Primary outcomes

  1. Cumulative proportion of hyperkalemia treatment

    Time frame: Within 3 hours

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

  2. Cumulative proportion of hypokalemia treatment

    Time frame: Within 3 hours

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

Secondary outcomes

  1. Cardiac arrest (sudden death)

    Time frame: Within 3 days

    Cardiac arrest (sudden death)

  2. Cumulative proportion of All-cause mortality

    Time frame: Within 365 days

    All-cause mortality

  3. Cumulative proportion of electric shock

    Time frame: Within 6 hours

    Cardioversion

  4. Cumulative proportion of CPR event

    Time frame: Within 6 hours

    Cardiopulmonary pesuscitation

  5. Cumulative proportion of Discharge

    Time frame: Within 14 days

    Discharge from inpatient department or emergency department

  6. Cumulative proportion of Treatment-induced hypokalemia event

    Time frame: Within 24 hours

    Treatment-induced hypokalemia event

  7. Cumulative proportion of Treatment-induced hyperkalemia event

    Time frame: Within 24 hours

    Treatment-induced hyperkalemia event

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Registry information

Official study title

Artificial Intelligence Identified Dyskalemia Using Electrocardiogram (AIDE) Prompts Immediate Treatment

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Nov 11, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.