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NCT Number: NCT06281977

Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Ottawa Heart Institute, Ottawa, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Other names: Precedex

normal saline

Drug

Programed as dexmedetomidine on infusion pump.

Primary outcomes

  1. 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

Secondary outcomes

  1. All-cause in-hospital death

    Time frame: Duration of index hospitalization - an average of 2 weeks

    Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo

  2. 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

  3. Resuscitated cardiac arrest 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

  4. Renal failure requiring new initiation of renal replacement therapy 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

  5. Intubation following 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

  6. Length of stay in the intensive care unit

    Time frame: Duration of index hospitalization - an average of 2 weeks

    Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo

  7. Length of stay in hospital

    Time frame: Duration of index hospitalization - an average of 2 weeks

    Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo

  8. Need for mechanical circulatory support device 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

  9. Ventricular Arrhythmia requiring treatment only during active study drug treatment

    Time frame: Duration of index hospitalization - an average of 2 weeks

    Defined as anytime the participant is receiving dexmedetomidine or normal saline placebo

  10. Pacing or treatment with isoproterenol for treatment of bradyarrhythmia 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

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Hibbert, MD PhD

CONTACT

[email protected]

F. Daniel Ramirez, MD MSc

CONTACT

[email protected]

613-696-7402

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Acronym: SEDATE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 28, 2024
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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