About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Dexmedetomidine
DrugDose range: 0.3 mcg/kg/hr to 1 mcg/kg/hr.
Normal saline
DrugProgramed as dexmedetomidine on infusion pump.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
All-cause in-hospital death
Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo
Ventricular arrhythmia requiring treatment after study drug initiation
Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo
Resuscitated cardiac arrest after study drug initiation
Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo
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
Sponsors and contacts
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