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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients randomized to intervention will be cared by physicians under AI-ECG support. |
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| Control | No Intervention | Patients randomized to control will be cared by routine practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac arrest (sudden death) | Cardiac arrest (sudden death) | Within 3 days |
| Cumulative proportion of All-cause mortality | All-cause mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Defense Medical Center | Taipei | 114 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41507124 | Derived | 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. |
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| ID | Term |
|---|---|
| D006947 | Hyperkalemia |
| D007008 | Hypokalemia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| Within 365 days |
| Cumulative proportion of electric shock | Cardioversion | Within 6 hours |
| Cumulative proportion of CPR event | Cardiopulmonary pesuscitation | Within 6 hours |
| Cumulative proportion of Discharge | Discharge from inpatient department or emergency department | Within 14 days |
| Cumulative proportion of Treatment-induced hypokalemia event | Treatment-induced hypokalemia event | Within 24 hours |
| Cumulative proportion of Treatment-induced hyperkalemia event | Treatment-induced hyperkalemia event | Within 24 hours |