Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm

Ventricular Tachycardia Clinical Trial

— SEDATE  

Official title:

Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06281977
• Other study ID #: ES613
• Status: Recruiting
• Phase: Phase 3
• Start date: May 8, 2024
• Est. completion date: August 1, 2027

Study information

• Verified date: June 2024
• Source: Ottawa Heart Institute Research Corporation
• Contact: F. Daniel Ramirez, MD MSc
• Phone: 613-696-7402
• Email: dramirez[@]ottawaheart.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: August 1, 2027
• Est. primary completion date: May 8, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Recurrent Ventricular Tachycardia
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Arrhythmias
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

Drug:
• Dexmedetomidine
Dose range: 0.3 mcg/kg/hr to 1 mcg/kg/hr.
• Normal saline
Programed as dexmedetomidine on infusion pump.

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is a composite of the following: 1. All-cause in-hospital death AND/OR 2. Any in-hospital ventricular arrhythmia requiring treatment after study drug initiation.	Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo	Duration of index hospitalization - an average of 2 weeks
Secondary	All-cause in-hospital death	Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo	Duration of index hospitalization - an average of 2 weeks
Secondary	Ventricular arrhythmia requiring treatment after study drug initiation	Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo	Duration of index hospitalization - an average of 2 weeks
Secondary	Resuscitated cardiac arrest after study drug initiation	Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo	Duration of index hospitalization - an average of 2 weeks
Secondary	Renal failure requiring new initiation of renal replacement therapy after study drug initiation	Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo	Duration of index hospitalization - an average of 2 weeks
Secondary	Intubation following study drug initiation	Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo	Duration of index hospitalization - an average of 2 weeks
Secondary	Length of stay in the intensive care unit	Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo	Duration of index hospitalization - an average of 2 weeks
Secondary	Length of stay in hospital	Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo	Duration of index hospitalization - an average of 2 weeks
Secondary	Need for mechanical circulatory support device after study drug initiation	Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo	Duration of index hospitalization - an average of 2 weeks
Secondary	Ventricular Arrhythmia requiring treatment only during active study drug treatment	Defined as anytime the participant is receiving dexmedetomidine or normal saline placebo	Duration of index hospitalization - an average of 2 weeks
Secondary	Pacing or treatment with isoproterenol for treatment of bradyarrhythmia after study drug initiation.	Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo	Duration of index hospitalization - an average of 2 weeks