Artificial Intelligence Identified Dyskalemia Using Electrocardiogram (AIDE)

Hyperkalemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05118022
• Other study ID #: NDMC2021004
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2023
• Source: National Defense Medical Center, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14989
• Est. completion date: February 28, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperkalemia
• Hypokalemia

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Defense Medical Center	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Defense Medical Center, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative proportion of hyperkalemia treatment	Calcium supplement, insulin, potassium binding resin, ß2-agonist, loop diuretics, sodium bicarbonate, and hemodialysis.	Within 3 hours
Primary	Cumulative proportion of hypokalemia treatment	Intravenous potassium chloride, oral potassium gluconate, and oral potassium chloride	Within 3 hours
Primary	Cumulative proportion of echocardiogram	Echocardiogram for patients with abnormal ECG.	Within 12 hours
Secondary	Cumulative proportion of ICU admission	ICU admission	Within 3 days
Secondary	Cumulative proportion of Discharge	Discharge from inpatient department or emergency department	Within 14 days
Secondary	Cumulative proportion of ED revisits in patients without hospitalization	ED revisits in patients without hospitalization	Within 30 days