Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Heart Institute Research Corporation

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine

    Drug

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

  • Normal saline

    Drug

    Programed as dexmedetomidine on infusion pump.

Treatment groups

192 Participants
are divided into 2 treatment groups
Group A: DexmedetomidineActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

All-cause in-hospital death

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

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

Ventricular arrhythmia requiring treatment after study drug initiation

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

Time frame
Duration of index hospitalization - an average of 2 weeks
3

Resuscitated cardiac arrest after study drug initiation

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

Time frame
Duration of index hospitalization - an average of 2 weeks
4

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

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

Other outcomes

Sponsors and contacts

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