Safety Endpoints and Outcome Measures
Outcomes related to sotalol dosing, changes in heart rate and QT/QTc interval in response to sotalol infusion and oral sotalol doses, and length of stay were assessed. Safety outcomes included the development of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF), bradycardia less than 50 bpm, and QT/QTc prolongation > 500 ms (or 550 ms for those with paced QRS or bundle branch block). All events were determined by review of electronic medical records, with heart rates and QT/QTc intervals determined by evaluation of ECGs obtained during clinical care.