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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Active Comparator | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Dose range: 0.3 mcg/kg/hr to 1 mcg/kg/hr. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Ventricular arrhythmia requiring treatment after study drug initiation |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| F. Daniel Ramirez, MD MSc | Contact | 613-696-7402 | dramirez@ottawaheart.ca | |
| Benjamin Hibbert, MD PhD | Contact | hibbert.benjamin@mayo.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Not yet recruiting | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41592634 | Derived | 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 Jan 25. |
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The study data, protocol, SAP, ICF, and CSR will be made available at study completion/publication.
Study completion
The above will be made publicly available
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D014693 | Ventricular Fibrillation |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Double-blind
| Normal saline | Drug | Programed as dexmedetomidine on infusion pump. |
|
Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo |
| Duration of index hospitalization - an average of 2 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| University of Ottawa Heart Institute | Recruiting | Ottawa | Ontario | K1Y 4W7 | Canada |
|
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |