NCT06281977

Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: Ottawa Heart Institute Research Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine if there is a meaningful benefit to using the sedative medication dexmedetomidine in the acute treatment of patients with recurrent ventricular arrhythmias, known as electrical storm. This will be a multi-centre, double-blinded, placebo-controlled, randomized trial. Patients with electrical storm will be randomized to receive 48 to 72 hours of dexmedetomidine or placebo as part of their initial treatment in an intensive care unit.

Detailed description

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.

Conditions

• Ventricular Tachycardia
• Ventricular Arrhythmias
• Ventricular Fibrillation
• Recurrent Ventricular Tachycardia

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Dose range: 0.3 mcg/kg/hr to 1 mcg/kg/hr.
DRUG	Normal saline	Programed as dexmedetomidine on infusion pump.

Timeline

• Start date: 2024-05-08
• Primary completion: 2027-05-08
• Completion: 2027-08-01
• First posted: 2024-02-28
• Last updated: 2025-12-17

Locations

1 site across 1 country: Canada