Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm

NCT06281977 | Recruiting Phase 3 DMC

• 1 other identifier: ES613
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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 Arrhythmias; Ventricular Fibrillation; Recurrent Ventricular Tachycardia; Ventricular Tachycardia

Keywords

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

Outcome Measures

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.

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

  Duration of index hospitalization - an average of 2 weeks

Secondary Outcomes (10)

• All-cause in-hospital death

  Duration of index hospitalization - an average of 2 weeks

• Ventricular arrhythmia requiring treatment after study drug initiation

  Duration of index hospitalization - an average of 2 weeks

• Resuscitated cardiac arrest after study drug initiation

  Duration of index hospitalization - an average of 2 weeks

• Renal failure requiring new initiation of renal replacement therapy after study drug initiation

  Duration of index hospitalization - an average of 2 weeks

• Intubation following study drug initiation

  Duration of index hospitalization - an average of 2 weeks

Study Arms (2)

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.

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.

Drug: Normal saline

Interventions

Dexmedetomidine DRUG

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

Also known as: Precedex

Dexmedetomidine

Normal saline DRUG

Programed as dexmedetomidine on infusion pump.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All patients admitted to an intensive care unit with electrical storm over the age of 18 years will be approached for enrollment.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 41592634 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Fibrillation

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

F. Daniel Ramirez, MD MSc

CONTACT

613-696-7402; dramirez@ottawaheart.ca

Benjamin Hibbert, MD PhD

CONTACT

hibbert.benjamin@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 28, 2024
• Study Start: May 8, 2024
• Primary Completion (Estimated): May 8, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Study completion
• Access Criteria: The above will be made publicly available

Locations

CA (1)