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.