The Effect of Prophylactic Intravenous Amiodarone Administration on Reperfusion Ventricular Fibrillation in Patients With Left Ventricular Hypertrophy Undergoing Cardiopulmonary Bypass Surgery: Protocol for a Randomized Double-Blind Clinical Trial

Abstract

Background Ventricular fibrillation (VF) is a common arrhythmia that occurs after the release of aortic cross-clamp (ACC) in patients undergoing cardiopulmonary bypass (CPB) surgery. Repeated defibrillation and long duration of VF could increase myocardial injuries. In patients with left ventricular hypertrophy (LVH), VF is easier to occur and more difficult to be terminated. Amiodarone, known as class III antiarrhythmic agent, has the prominent properties of converting VF and restoring the sinus rhythm. Before ACC release, administration of amiodarone has been confirmed useful to reduce occurrence of VF. However, few studies are focused on the effect of amiodarone before ACC release on reducing VF in patients with LVH. Objective This study aimed at determining the efficacy of prophylactic intravenous amiodarone administration on reperfusion VF after release of ACC in patients with LVH undergoing CPB surgery. Methods This will be a prospective, randomized, double-blind, placebo-controlled trial. The trial will enroll 54 patients with LVH aged 18-75 years who will undergo CPB surgery. All eligible participants will be randomly allocated to either the amiodarone or placebo group by using the block randomization in a 1:1 ratio. The primary end point will be the incidence rate of VF 30 minutes after ACC release and be assessed using the Fisher exact test. All data will be analyzed in accordance with the intention-to-treat principle. Results The study began in August 2022, and the data collection will take place for the next 2 academic years. As of this writing, 21 participants have already been recruited for the study. Conclusions With this trial, we are hoping to demonstrate that prophylactic infusion of amiodarone before ACC release could reduce the occurrence of reperfusion VF in patients with LVH. Trial Registration ClinicalTrials.gov ChiCTR2000035057; https://www.chictr.org.cn/showprojen.aspx?proj=57145 International Registered Report Identifier (IRRID) DERR1-10.2196/40115