Atrial Fibrillation Clinical Trial
Official title:
Using Time-dependent Intravenous Infusions of Amiodarone for Conversions to Sinus Rhythms in Patients With Paroxysmal Atrial Fibrillation
Sixty consecutive emergency patients with newly diagnosed Atrial Fibrillation were randomized
into two groups. The first received intravenous amiodarone infusions continuously for 24
hours; the second received Amiodarone until sinus rhythms was reached or for up to 72 hours.
The efficacy and safety of administering intravenous infusions of amiodarone for up to 72
hours were investigated and compared to the efficacy and safety of administering a standard
24 hours infusion of amiodarone. Specifically, the use of up to 72 hours infusions was
considered as a new strategy to improve rates of conversion to sinus rhythm without altering
the safety profile of the drug.
An open randomized clinical trial was conducted that included 60 emergency adult patients who
were candidates for drug cardioversion after first symptomatic episodes of AF.
The patients were randomized in equal proportions and sequentially placed in one of two
treatment groups; no patient knew to which group he or she belonged. The first group received
intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg
until 24 hours was reached. The second group received intravenous amiodarone infusions at
doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg every 24 hours for up to 72 hours.
All patients were continuously monitored using electrocardiograms, and echocardiograms were
performed within 24 hours after the randomized trial began. The exact time of each patient's
cardioversion was documented. In addition, general laboratory tests, lipid profiles, thyroid
profiles and chest X-rays were obtained for all patients.
A sample size of 30 subjects in each group was calculated. A conversion rate of 60% was
assumed, according to literature, and an estimated increase to 90% was assumed for the
experimental group to find differences with a power of 0.8 and an alpha error of 0.05.
The primary goal was to obtain was a sinus rhythm conversion rate. The secondary goal was to
obtain a combined complication rate by noting various complications in the patients, such as
phlebitis, symptomatic hypotension that required vasopressors, bradycardia, nausea, vomiting
and any organ embolism.
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