HyperkalemiaNCT05118022
Artificial Intelligence Identified Dyskalemia Using Electrocardiogram (AIDE)
A study testing Artificial Intelligence identified Dyskalemia using Electrocardiogram (AIDE) system in people with Hyperkalemia and Hypokalemia, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperkalemia, Hypokalemia
- What is being tested?
- Artificial Intelligence identified Dyskalemia using Electrocardiogram (AIDE) system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,989 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in emergency department.
- Patients recieved at least 1 ECG examination.
Who cannot join
- Patients recieved dyskalemia-related treatment before ECG examination.
- The patients recieved ECG at the period of inactive AI-ECG system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Artificial Intelligence Identified Dyskalemia Using Electrocardiogram (AIDE) Prompts Immediate Treatment
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.
- Conditions
- Hyperkalemia, Hypokalemia
- Being tested
- Artificial Intelligence identified Dyskalemia using Electrocardiogram (AIDE) system
- Medical subject headings
- Hyperkalemia, Hypokalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients randomized to intervention will be cared by physicians under AI-ECG support. Receives: Other: Artificial Intelligence identified Dyskalemia using Electrocardiogram (AIDE) system |
| Control | No intervention | Patients randomized to control will be cared by routine practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative proportion of hyperkalemia treatment
Calcium supplement, insulin, potassium binding resin, β2-agonist, loop diuretics, sodium bicarbonate, and hemodialysis.
Measured: Within 3 hours
Cumulative proportion of hypokalemia treatment
Intravenous potassium chloride, oral potassium gluconate, and oral potassium chloride
Measured: Within 3 hours
Secondary outcomes (7)
Cardiac arrest (sudden death)
Cardiac arrest (sudden death)
Measured: Within 3 days
Cumulative proportion of All-cause mortality
All-cause mortality
Measured: Within 365 days
Cumulative proportion of electric shock
Cardioversion
Measured: Within 6 hours
Cumulative proportion of CPR event
Cardiopulmonary pesuscitation
Measured: Within 6 hours
Cumulative proportion of Discharge
Discharge from inpatient department or emergency department
Measured: Within 14 days
Cumulative proportion of Treatment-induced hypokalemia event
Treatment-induced hypokalemia event
Measured: Within 24 hours
Cumulative proportion of Treatment-induced hyperkalemia event
Treatment-induced hyperkalemia event
Measured: Within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Jan 2022
- Primary completion31 Oct 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14,989 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin Lin, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118022
- Sponsor's protocol ID
- NDMC2021004
- Status last verified
- Sep 2024
- First submitted
- 1 Nov 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41507124
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Identified Dyskalemia Using Electrocardiogram (AIDE) Prompts Immediate Treatment
- ClinicalTrials.gov ID
- NCT05118022
- Acronym / sponsor ID
- NDMC2021004
- Conditions
- Hyperkalemia, Hypokalemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14,989 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Artificial Intelligence identified Dyskalemia using Electrocardiogram (AIDE) systemPatients randomized to intervention will be cared by physicians under AI-ECG support. |
| Control | No intervention | –Patients randomized to control will be cared by routine practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients in emergency department.
- Patients recieved at least 1 ECG examination.
Key exclusion criteria (2 listed)
- Patients recieved dyskalemia-related treatment before ECG examination.
- The patients recieved ECG at the period of inactive AI-ECG system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial Intelligence identified Dyskalemia using Electrocardiogram (AIDE) systemOnce 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. | Other | Intervention |
Primary outcome
Cumulative proportion of hyperkalemia treatment
Time frame: Within 3 hours
Calcium supplement, insulin, potassium binding resin, β2-agonist, loop diuretics, sodium bicarbonate, and hemodialysis.
Cumulative proportion of hypokalemia treatment
Time frame: Within 3 hours
Intravenous potassium chloride, oral potassium gluconate, and oral potassium chloride
7 secondary outcomes
Cardiac arrest (sudden death)
Time frame: Within 3 days
Cumulative proportion of All-cause mortality
Time frame: Within 365 days
Cumulative proportion of electric shock
Time frame: Within 6 hours
Cumulative proportion of CPR event
Time frame: Within 6 hours
Cumulative proportion of Discharge
Time frame: Within 14 days
Cumulative proportion of Treatment-induced hypokalemia event
Time frame: Within 24 hours
Cumulative proportion of Treatment-induced hyperkalemia event
Time frame: Within 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 41507124Lin 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.
- Individual participant dataSharing planned: No
Related trials for Hyperkalemia
Not yet recruiting
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Chronic Kidney Disease
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A Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
Hyperkalemia
Enrolling by invitationPhase 4
Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
Chronic Kidney Disease, Type 2 Diabetes
Recruiting
Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited Potassium Content in Patients With Chronic Kidney Disease: A Pilot Study
Hyperkalemia, Chronic Kidney Disease (Stages 4 and 5)
RecruitingPhase 2
Effect of Patiromer in Children Under 12 Years of Age With High Blood Potassium Levels
Hyperkalemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence identified Dyskalemia using Electrocardiogram (AIDE) system in people with Hyperkalemia and Hypokalemia, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative proportion of hyperkalemia treatment (time frame: Within 3 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05118022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.