HyperkalemiaREACTNCT05441852
A Study to Detect Hyperkalemia Using Smartphone-enabled Electrocardiogram (EKG)
An observational study of Hyperkalemia, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to validate the real-world performance of a previously developed Artificial Intelligence - Electrocardiogram (AI-ECG) algorithm for identification of hyperkalemia with a six-lead mobile-enhanced device . Read more about this study
- Who is it for?
- Ages 50 to 89 years
- Conditions the study is for
- Hyperkalemia
- How many people
- 1,151 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2022to 7 Jul 2023
- Phase
- Observational
- 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 50 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the emergency department who meet the above inclusion criteria. Patients with the above inclusion criteria experience hyperkalemia more frequently than the general population at a prevalence near 10% compared to 2-4%, respectively.
Who may be able to join
- Age greater than/equal to 50 years and able to provide consent.
- Patients with eGFR (from serum creatinine) < 45 ml/minute and/or a history of serum potassium > 5.2 mEq/l.
Who cannot join
- Patients underage < 50.
- Do not meet inclusion criteria.
- Unstable patients requiring emergent resuscitation.
- Patients unable to provide consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rapid dEtection of HyperkAlemia (K+) in the EmergenCy Department Using a SmarTphone-enabled Single-lead EKG (REACT)
The purpose of this study is to validate the real-world performance of a previously developed Artificial Intelligence - Electrocardiogram (AI-ECG) algorithm for identification of hyperkalemia with a six-lead mobile-enhanced device .
Read the detailed description
- Ambulatory adult patients in the Emergency Department (ED) at increased risk for hyperkalemia (due to age ≥ 50 years, and one or more criteria including estimated Glomerular filtration rate (eGFR) (from serum creatinine) < 45 ml/minute and/or a history of serum potassium > 5.2 milliequivalents per liter (mEq/l) who present to the emergency department will be approached to consent for the rapid screening process.
- Those who consent will undergo 30 second 6 L ECG recording with a portable, mobile-enhanced device (AliveCor Kardia).
- This ECG data is subsequently evaluated by our artificial intelligence algorithm to detect hyperkalemia, and the estimated probability of hyperkalemia is recorded.
- The research team notifies supervising Emergency Department staff of patients whose probability of hyperkalemia is significantly elevated above the optimized cutoff point according to the AI-ECG algorithm.
- Conditions
- Hyperkalemia
- Keywords
- electrocardiogram (ECG), Artificial Intelligence (AI), neural network, hyperkalemia, Emergency Department (ED), Smartphone, AliveCor Kardia 6 L ECG device
- Medical subject headings
- Hyperkalemia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory Emergency Department Patients at risk for hyperkalemia | Patients who are at elevated risk for hyperkalemia identified during a visit to the emergency department. Elevated risk individuals are defined in this study as: >50 years of age, eGFR <45, or prior K >5.2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperkalemia detection by AI enhanced ECG
Understanding model's ability to predict hyperkalemia as determined by the area under the receiver operating characteristic
Measured: 12 months
Secondary outcomes (1)
Performance metrics for the detection of hyperkalemia by AI enhanced ECG
Detailed performance metrics of the algorithm (sensitivity, specificity, positive predictive value and negative predictive value) will be calculated using an optimized cutoff threshold determined from the primary outcome.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start31 Mar 2022
- Primary completion7 Jul 2023
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Dillon, Mayo Clinic
- Investigators
- John Dillon, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441852
- Sponsor's protocol ID
- 21-006298
- Acronym
- REACT
- Status last verified
- Jul 2023
- First submitted
- 9 Jun 2022
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to patient confidentiality and IRB rules, we will not make individual patient data available
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid dEtection of HyperkAlemia (K+) in the EmergenCy Department Using a SmarTphone-enabled Single-lead EKG (REACT)
- ClinicalTrials.gov ID
- NCT05441852
- Acronym / sponsor ID
- REACT / 21-006298
- Conditions
- Hyperkalemia
- Keywords
- electrocardiogram (ECG), Artificial Intelligence (AI), neural network, hyperkalemia, Emergency Department (ED), Smartphone, AliveCor Kardia 6 L ECG device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,151 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 1 Jul 2022 (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.
The purpose of this study is to validate the real-world performance of a previously developed Artificial Intelligence - Electrocardiogram (AI-ECG) algorithm for identification of hyperkalemia with a six-lead mobile-enhanced device .
Detailed description
- Ambulatory adult patients in the Emergency Department (ED) at increased risk for hyperkalemia (due to age ≥ 50 years, and one or more criteria including estimated Glomerular filtration rate (eGFR) (from serum creatinine) < 45 ml/minute and/or a history of serum potassium > 5.2 milliequivalents per liter (mEq/l) who present to the emergency department will be approached to consent for the rapid screening process.
- Those who consent will undergo 30 second 6 L ECG recording with a portable, mobile-enhanced device (AliveCor Kardia).
- This ECG data is subsequently evaluated by our artificial intelligence algorithm to detect hyperkalemia, and the estimated probability of hyperkalemia is recorded.
- The research team notifies supervising Emergency Department staff of patients whose probability of hyperkalemia is significantly elevated above the optimized cutoff point according to the AI-ECG algorithm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ambulatory Emergency Department Patients at risk for hyperkalemia | – | –Patients who are at elevated risk for hyperkalemia identified during a visit to the emergency department. Elevated risk individuals are defined in this study as: >50 years of age, eGFR <45, or prior K >5.2 |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the emergency department who meet the above inclusion criteria. Patients with the above inclusion criteria experience hyperkalemia more frequently than the general population at a prevalence near 10% compared to 2-4%, respectively.
Key inclusion criteria (2 listed)
- Age greater than/equal to 50 years and able to provide consent.
- Patients with eGFR (from serum creatinine) < 45 ml/minute and/or a history of serum potassium > 5.2 mEq/l.
Key exclusion criteria (4 listed)
- Patients underage < 50.
- Do not meet inclusion criteria.
- Unstable patients requiring emergent resuscitation.
- Patients unable to provide consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hyperkalemia detection by AI enhanced ECG
Time frame: 12 months
Understanding model's ability to predict hyperkalemia as determined by the area under the receiver operating characteristic
1 secondary outcome
Performance metrics for the detection of hyperkalemia by AI enhanced ECG
Time frame: 12 months
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 14 Jul 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Due to patient confidentiality and IRB rules, we will not make individual patient data available
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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.
John Dillon, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperkalemia, run by Mayo Clinic at 1 site in United States.
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 4 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 14 Jul 2023. 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 United States. 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?
Hyperkalemia detection by AI enhanced ECG (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2023.