Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm

Electrical storm (ES), defined as three or more sustained or treated ventricular arrhythmias in a 24-hour period, is a life-threatening condition that is associated with significant short- and long-term mortality. Autonomic dysfunction from increased sympathetic tone and the catecholamine surge from defibrillator shocks can precipitate recurrent ventricular arrhythmias and exacerbate ES. Although the mainstay of treatment are anti-arrhythmic drugs, sedative agents and procedures are commonly used to decrease sympathetic tone. These therapies have been studied in refractory ES but the benefit of early sedation remains unclear.

Alpha-2 agonism with dexmedetomidine can provide conscious sedation without the need for mechanical ventilation. Dexmedetomidine has been found to reduce ventricular arrhythmia events in non-ES patients in the intensive care unit and in the peri-operative period. Its antiarrhythmic properties are thought to be due to catecholamine suppression, prolonging electrical refractory periods, and increasing vagal tone. Its rapid onset and favorable safety profile render alpha-2 agonism with dexmedetomidine a potentially valuable therapy for patients with ES.

This study is a multi-centre, double-blinded, placebo-controlled, randomized trial that will evaluate the effectiveness of dexmedetomidine in the acute treatment of ES. Consecutive patients admitted to an intensive care unit will be randomized to receive dexmedetomidine or placebo at the time of presentation. The study drug will be titrated to a maintenance dose and continued for 48 hours before being weaned.

• All-cause in-hospital death [Срок оценки: Duration of index hospitalization - an average of 2 weeks]
• Ventricular arrhythmia requiring treatment after study drug initiation [Срок оценки: Duration of index hospitalization - an average of 2 weeks]
• Resuscitated cardiac arrest after study drug initiation [Срок оценки: Duration of index hospitalization - an average of 2 weeks]
• Renal failure requiring new initiation of renal replacement therapy after study drug initiation [Срок оценки: Duration of index hospitalization - an average of 2 weeks]
• Intubation following study drug initiation [Срок оценки: Duration of index hospitalization - an average of 2 weeks]
• Length of stay in the intensive care unit [Срок оценки: Duration of index hospitalization - an average of 2 weeks]
• Length of stay in hospital [Срок оценки: Duration of index hospitalization - an average of 2 weeks]
• Need for mechanical circulatory support device after study drug initiation [Срок оценки: Duration of index hospitalization - an average of 2 weeks]
• Ventricular Arrhythmia requiring treatment only during active study drug treatment [Срок оценки: Duration of index hospitalization - an average of 2 weeks]
• Pacing or treatment with isoproterenol for treatment of bradyarrhythmia after study drug initiation. [Срок оценки: Duration of index hospitalization - an average of 2 weeks]