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Dexmedetomidine in the Acute Treatment of Electrical Storm
NCT06281977Phase 3
Key facts
- Status
- Recruiting
- Start
- May 2024
- Primary completion
- May 2027
- Countries
- 2
- Sponsor
- University of Ottawa Heart Institute
- Modality
- Small Molecules
- Drugs
- dexmedetomidine
- Conditions
- Electrical Storm (ES)
01
Overview
Phase 3, randomised, double-blind trial in Electrical Storm (ES) comparing Dexmedetomidine with Placebo (2 arms). Primary endpoint: Composite of All-cause In-hospital Death and/or Any In-hospital Ventricular Arrhythmia Requiring Treatment at 2 weeks. Started May 2024; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Dexmedetomidine
Dexmedetomidine started at 0.3 mcg/kg/hr and titrated to a target dose of 1.0 mcg/kg/hr for 48 ± 6 hours.
Placebo
Normal saline programmed as dexmedetomidine on infusion pump for 48 ± 6 hours.
03
Who it enrols
Adult patients admitted to an intensive care unit with electrical storm, excluding those with refractory shock, SCAI class D or E cardiogenic shock, prolonged cardiac arrest, STEMI-induced VA, severe bradycardia, pregnancy, or recent use of dexmedetomidine or clonidine.
04
Endpoints
Primary
Composite of All-cause In-hospital Death and/or Any In-hospital Ventricular Arrhythmia Requiring Treatment
Secondary
All-cause In-hospital Death
Ventricular Arrhythmia Requiring Treatment After Study Drug Initiation
Resuscitated Cardiac Arrest After Study Drug Initiation
Renal Failure Requiring New Initiation of Renal Replacement Therapy
Intubation Following Study Drug Initiation
Length of Stay in the Intensive Care Unit
Length of Stay in Hospital
Need for Mechanical Circulatory Support Device After Study Drug Initiation
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