Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Ottawa Heart Institute Research Corporation
Study ID
NCT06281977
Phase
PHASE3
Status
Recruiting
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Conditions

  • Recurrent Ventricular Tachycardia
  • Ventricular Arrhythmias
  • Ventricular Fibrillation
  • Ventricular Tachycardia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexmedetomidine — DRUG
    Dose range: 0.3 mcg/kg/hr to 1 mcg/kg/hr.
  • Normal saline — DRUG
    Programed as dexmedetomidine on infusion pump.

Study Details

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.

Key Dates

Start date
May 8, 2024
Status verified
Dec 2025
Primary completion
May 8, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
192 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Pietro Di Santo, MD PhD
[email protected]
507-255-4622

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Mayo Clinic· Rochester, MN

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