Nifekalant Versus Amiodarone in New-Onset Atrial Fibrillation After Cardiac Surgery
Status:
Not yet recruiting
Trial end date:
2024-06-01
Target enrollment:
Participant gender:
Summary
Postoperative atrial fibrillation is a major complication of cardiac surgery, which could
lead to high morbidity and mortality, increase duration of hospital stay and increase the
cost of treatment. New-onset atrial fibrillation after cardiac surgery is considered as a
multifactorial phenomenon. Amiodarone, the most commonly used drug for cardioversion, is
limited in atrial fibrillation after cardiac surgery due to side effects such as hypotension,
bradycardia, and extracardiac side effects. Nifekalant is a novel class III antiarrhythmic
agent with short onset time. It is a pure potassium channel blocker, which generally does not
cause hypotension and bradycardia. There have been several trials that proven efficacy of
nifekalant in converting persistent atrial fibrillation. For atrial fibrillation after
cardiac surgery, the effectiveness and safety of nifekalant compared to amiodarone have not
yet been reported. We plan to perform a clinical trial comparing nifekalant to amiodarone in
new-onset atrial fibrillation after cardiac surgery patients with a primary outcome of
cardioversion at 4 hours. Secondary outcomes will follow cardioversion at 90 minutes and 24
hours, maintenance time of sinus rhythm within 24 hours, average time to conversion to sinus
rhythm, rate of hypotension, length of ICU stay, length of hospital stay and hospital
mortality.