RecruitingPhase 3NCT06281977

Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm


Sponsor

Ottawa Heart Institute Research Corporation

Enrollment

192 participants

Start Date

May 8, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

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

Exclusion Criteria9

  • 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

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Interventions

DRUGDexmedetomidine

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

DRUGNormal saline

Programed as dexmedetomidine on infusion pump.


Locations(1)

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

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NCT06281977


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