A Study to Detect Hyperkalemia Using Smartphone-enabled Electrocardiogram (EKG) (REACT)

Mayo Clinic

Status: Completed

Conditions: Hyperkalemia

Study type: Observational

Funder types: Other

Identifiers

NCT05441852

21-006298

Details and patient eligibility

About

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 .

Full description

1. 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.
2. Those who consent will undergo 30 second 6 L ECG recording with a portable, mobile-enhanced device (AliveCor Kardia).
3. This ECG data is subsequently evaluated by our artificial intelligence algorithm to detect hyperkalemia, and the estimated probability of hyperkalemia is recorded.
4. 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.

Enrollment: 1,151 patients

Sex: All

Ages: 50 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Patients underage < 50.
• Do not meet inclusion criteria.
• Unstable patients requiring emergent resuscitation.
• Patients unable to provide consent.

Trial design

1,151 participants in 1 patient group

Ambulatory Emergency Department Patients at risk for hyperkalemia

Description:

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