Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexmedetomidine, Normal saline.
- Who it may be relevant to
- Registry conditions: Ventricular Tachycardia, Ventricular Arrhythmias, Ventricular Fibrillation, Recurrent Ventricular Tachycardia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Dexmedetomidine
Dose range: 0.3 mcg/kg/hr to 1 mcg/kg/hr. - Drug Normal saline
Programed as dexmedetomidine on infusion pump.
Primary outcome measures
- 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. [Time frame: Duration of index hospitalization - an average of 2 weeks]
Secondary outcome measures (10)
- All-cause in-hospital death [Time frame: Duration of index hospitalization - an average of 2 weeks]
- Ventricular arrhythmia requiring treatment after study drug initiation [Time frame: Duration of index hospitalization - an average of 2 weeks]
- Resuscitated cardiac arrest after study drug initiation [Time frame: Duration of index hospitalization - an average of 2 weeks]
- Renal failure requiring new initiation of renal replacement therapy after study drug initiation [Time frame: Duration of index hospitalization - an average of 2 weeks]
- Intubation following study drug initiation [Time frame: Duration of index hospitalization - an average of 2 weeks]
- Length of stay in the intensive care unit [Time frame: Duration of index hospitalization - an average of 2 weeks]
- Length of stay in hospital [Time frame: Duration of index hospitalization - an average of 2 weeks]
- Need for mechanical circulatory support device after study drug initiation [Time frame: Duration of index hospitalization - an average of 2 weeks]
- Ventricular Arrhythmia requiring treatment only during active study drug treatment [Time frame: Duration of index hospitalization - an average of 2 weeks]
- Pacing or treatment with isoproterenol for treatment of bradyarrhythmia after study drug initiation. [Time frame: Duration of index hospitalization - an average of 2 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Canada · 1 center
- University of Ottawa Heart Institute — Ottawa
Publications
- Motazedian P, Di Santo P, Prosperi-Porta G, Nelson D, Morgan B, Ratelle C, Feagan H, Koopman Z, Jung R, Mathieu ME, Knoll W, Parlow S, Abdel-Razek O, Mathew R, Wells GA, Chiu MH, Ballantyne B, Hibbert B, Ramirez FD. Study evaluating dexmedetomidine in the acute treatment of electrical storm (SEDATE): Rationale and design. Am Heart J. 2026 May;295:107358. doi: 10.1016/j.ahj.2026.107358. Epub 2026 J PMID 41592634
Identifiers
NCT: NCT06281977 · ES613