Recruiting
Phase 3

Dexmedetomidine

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT06281977

Conditions

Ventricular Tachycardia

Ventricular Arrhythmias

Ventricular Fibrillation

Recurrent Ventricular Tachycardia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dexmedetomidine

Normal saline

Study Details

Brief 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.

Conditions

Ventricular Tachycardia

Ventricular Arrhythmias

Ventricular Fibrillation

Recurrent Ventricular Tachycardia

Study ID

NCT06281977

Start date

May 8, 2024

Status verified date

Dec, 2025

Completion date

Aug 1, 2027

Anticipated

Primary completion date

May 8, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

192 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Dexmedetomidine

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 comparator: Placebo

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.

Interventions

Dexmedetomidine

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

Normal saline

Programed as dexmedetomidine on infusion pump.

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 ]

Central Contacts and Locations

Central contacts

F. Daniel Ramirez, MD MSc

613-696-7402dramirez@ottawaheart.ca

Benjamin Hibbert, MD PhD

hibbert.benjamin@mayo.edu

Locations

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Contacts

F Daniel Ramirez, MD

613-696-7402dramirez@ottawaheart.ca

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

Jul 7, 2026

Last verified

Dec, 2025

Keywords

  • Electrical Storm
  • Dexmedetomidine
  • Ventricular Electrical Storm
  • Precedex
  • Recurrent Ventricular Arrhythmias
  • Recurrent Ventricular Tachycardia
  • Sedation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2026-07-07.