Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• \- All patients admitted to an intensive care unit with electrical storm over the age of 18 years will be approached for enrollment.
Locations
Other Locations
Canada
University of Ottawa Heart Institute
RECRUITING
Ottawa
Contact Information
Primary
F. Daniel Ramirez, MD MSc
dramirez@ottawaheart.ca
613-696-7402
Backup
Benjamin Hibbert, MD PhD
hibbert.benjamin@mayo.edu
Time Frame
Start Date: 2024-05-08
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 192
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Ottawa Heart Institute Research Corporation