Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm

NCT ID: NCT06281977

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-08
• Study Completion Date: 2027-08-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dexmedetomidine

Participants randomized to receive dexmedetomidine will be started at a dose of 0.3 mcg/kg/hr and titrated to a target dose of 1.0 mcg/kg/hr. Once the participant reaches their maximum tolerated dose (as decided by the blinded treating physician), they will continue treatment for 48 ± 6 hours. This will be followed by a weaning phase that will similarly be at the discretion of the treating physician.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

Dose range: 0.3 mcg/kg/hr to 1 mcg/kg/hr.

Placebo

Participants randomized to receive placebo will be started on normal saline. In similar fashion to the active comparator, participants will be titrated to their maximal tolerated dose, continue treatment for 48 ± 6 hours, and be weaned at the discretion of the blinded treating physician.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Programed as dexmedetomidine on infusion pump.

Interventions

Dexmedetomidine

Dose range: 0.3 mcg/kg/hr to 1 mcg/kg/hr.

Intervention Type: DRUG

Normal saline

Programed as dexmedetomidine on infusion pump.

Intervention Type: DRUG

Other Intervention Names

Precedex

Eligibility Criteria

Inclusion Criteria

• All patients admitted to an intensive care unit with electrical storm over the age of 18 years will be approached for enrollment.

Exclusion Criteria

• Refractory shock lasting for more than 30 minutes unrelated to ventricular arrhythmias (VAs), defined as requiring two or more vasopressors
• SCAI class D or E cardiogenic shock
• Cardiac arrest(s) with a no-flow and low-flow total time of greater than 10 minutes prior to recruitment.
• ST-segment elevation myocardial infarction (STEMI)-induced VA with signs of active ischemia.
• Bradycardia with heart rate less than 40 beats per minute, bradycardia-induced ventricular tachyarrhythmia, second degree Mobitz type 2 or greater atrioventricular block in the absence of a pacemaker.
• Pregnancy
• Known dexmedetomidine allergy or intolerance
• Inability to obtain consent from patient or substitute decision maker.
• Patients who have received dexmedetomidine or clonidine during the 24 hours prior to randomization

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

F. Daniel Ramirez, MD MSc

Role: CONTACT

dramirez@ottawaheart.ca

613-696-7402

Benjamin Hibbert, MD PhD

Role: CONTACT

hibbert.benjamin@mayo.edu

Facility Contacts

F Daniel Ramirez, MD

Role: primary

dramirez@ottawaheart.ca

613-696-7402

Other Identifiers

ES613

Identifier Type: -

Identifier Source: org_study_id