Ventricular TachycardiaPhase 3SEDATENCT06281977
Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm
A Phase 3 study testing Dexmedetomidine and Normal saline in people with Ventricular Tachycardia and Ventricular Arrhythmias, run by Ottawa Heart Institute Research Corporation at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Ventricular Arrhythmias, Ventricular Fibrillation
- What is being tested?
- Dexmedetomidine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 May 2024to 1 Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients admitted to an intensive care unit with electrical storm over the age of 18 years will be approached for enrollment.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Benjamin Hibbert, MD PhD contact
2 sites in 2 countries
United States1 site, 1 recruiting
- Not yet recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Pietro Di Santo, MD PhD, 507-255-4622, disanto.pietro@mayo.edu
Canada1 site, 1 recruiting
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
F Daniel Ramirez, MD, 613-696-7402, dramirez@ottawaheart.ca
About this study
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.
Read the 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
- Being tested
- Dexmedetomidine, Normal saline
- Keywords
- Electrical Storm, Dexmedetomidine, Ventricular Electrical Storm, Precedex, Recurrent Ventricular Arrhythmias, Recurrent Ventricular Tachycardia, Sedation
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Dose range: 0.3 mcg/kg/hr to 1 mcg/kg/hr.
Normal salineDrug
Programed as dexmedetomidine on infusion pump.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dexmedetomidine |
| 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. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Duration of index hospitalization - an average of 2 weeks
Secondary outcomes (10)
All-cause in-hospital death
Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo
Measured: Duration of index hospitalization - an average of 2 weeks
Ventricular arrhythmia requiring treatment after study drug initiation
Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Duration of index hospitalization - an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start8 May 2024
- Primary completion8 May 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281977
- Sponsor's protocol ID
- ES613
- Acronym
- SEDATE
- Status last verified
- Dec 2025
- First submitted
- 9 Feb 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study data, protocol, SAP, ICF, and CSR will be made available at study completion/publication.
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 Jan 25.
PubMed 41592634
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm
- ClinicalTrials.gov ID
- NCT06281977
- Acronym / sponsor ID
- SEDATE / ES613
- Conditions
- Ventricular Tachycardia, Ventricular Arrhythmias, Ventricular Fibrillation, Recurrent Ventricular Tachycardia
- Keywords
- Electrical Storm, Dexmedetomidine, Ventricular Electrical Storm, Precedex, Recurrent Ventricular Arrhythmias, Recurrent Ventricular Tachycardia, Sedation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 8 May 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: DexmedetomidineParticipants 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 | Drug: Normal salineParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to an intensive care unit with electrical storm over the age of 18 years will be approached for enrollment.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: PrecedexDose range: 0.3 mcg/kg/hr to 1 mcg/kg/hr. | Drug | Dexmedetomidine |
| Normal salineProgramed as dexmedetomidine on infusion pump. | Drug | Placebo |
Primary outcome
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
Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Derived from this study: PubMed 41592634Motazedian 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.
- Individual participant dataSharing planned: Yes. The study data, protocol, SAP, ICF, and CSR will be made available at study completion/publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Hibbert, MD PhD contact
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine and Normal saline in people with Ventricular Tachycardia and Ventricular Arrhythmias, run by Ottawa Heart Institute Research Corporation at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact F. Daniel Ramirez, MD MSc (613-696-7402, dramirez@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06281977, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.