Dexmedetomidine
DrugDose range: 0.3 mcg/kg/hr to 1 mcg/kg/hr.
Other names: Precedex
NCT Number: NCT06281977
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
University of Ottawa Heart Institute, Ottawa, Ontario, Canada
Electrical storm (ES), defined as three or more sustained or treated ventricular arrhythmias in a 24-hour period, is a life-threatening condition that is associated with significant short- and long-term mortality. Autonomic dysfunction from increased sympathetic tone and the catecholamine surge from defibrillator shocks can precipitate recurrent ventricular arrhythmias and exacerbate ES. Although the mainstay of treatment are anti-arrhythmic drugs, sedative agents and procedures are commonly used to decrease sympathetic tone. These therapies have been studied in refractory ES but the benefit of early sedation remains unclear.
Alpha-2 agonism with dexmedetomidine can provide conscious sedation without the need for mechanical ventilation. Dexmedetomidine has been found to reduce ventricular arrhythmia events in non-ES patients in the intensive care unit and in the peri-operative period. Its antiarrhythmic properties are thought to be due to catecholamine suppression, prolonging electrical refractory periods, and increasing vagal tone. Its rapid onset and favorable safety profile render alpha-2 agonism with dexmedetomidine a potentially valuable therapy for patients with ES.
This study is a multi-centre, double-blinded, placebo-controlled, randomized trial that will evaluate the effectiveness of dexmedetomidine in the acute treatment of ES. Consecutive patients admitted to an intensive care unit will be randomized to receive dexmedetomidine or placebo at the time of presentation. The study drug will be titrated to a maintenance dose and continued for 48 hours before being weaned.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dose range: 0.3 mcg/kg/hr to 1 mcg/kg/hr.
Other names: Precedex
Programed as dexmedetomidine on infusion pump.
Time frame: Duration of index hospitalization - an average of 2 weeks
Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo
Time frame: Duration of index hospitalization - an average of 2 weeks
Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo
Time frame: Duration of index hospitalization - an average of 2 weeks
Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo
Time frame: Duration of index hospitalization - an average of 2 weeks
Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo
Time frame: Duration of index hospitalization - an average of 2 weeks
Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo
Time frame: Duration of index hospitalization - an average of 2 weeks
Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo
Time frame: Duration of index hospitalization - an average of 2 weeks
Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo
Time frame: Duration of index hospitalization - an average of 2 weeks
Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo
Time frame: Duration of index hospitalization - an average of 2 weeks
Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo
Time frame: Duration of index hospitalization - an average of 2 weeks
Defined as anytime the participant is receiving dexmedetomidine or normal saline placebo
Time frame: Duration of index hospitalization - an average of 2 weeks
Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo
Contact information is provided by the study sponsor or research team.
Benjamin Hibbert, MD PhD
CONTACT
F. Daniel Ramirez, MD MSc
CONTACT
Ottawa Heart Institute Research Corporation
Other
Acronym: SEDATE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07324031
Arrhythmias, Cardiac, Cardiac Conduction System Disease
Scottsdale, Arizona, United States
View Trial DetailsNCT05720936
Arrhythmias, Cardiac, Arrhythmic Storm
Alessandria, AL, Italy
View Trial DetailsNCT06324682
Arrhythmias, Cardiac, Atrial Fibrillation
Ferrara, FE, Italy
View Trial DetailsNCT03360227
Arrhythmias, Cardiac, Bradycardia
Düsseldorf, Germany
View Trial Details