Evaluating dexmedetomidine for treating electrical storm in patients
Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm
PHASE3 · Ottawa Heart Institute Research Corporation · NCT06281977
This study is testing if a sedative called dexmedetomidine can help adults with electrical storm, which causes dangerous heart rhythms, by reducing these episodes and improving their recovery.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Heart Institute Research Corporation (other) |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT06281977 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of dexmedetomidine, a sedative medication, in the acute treatment of patients experiencing electrical storm, characterized by recurrent ventricular arrhythmias. It is a multi-centre, double-blinded, placebo-controlled, randomized trial where patients will receive either dexmedetomidine or a placebo for 48 to 72 hours in an intensive care unit setting. The study seeks to determine if early sedation can reduce the frequency of life-threatening arrhythmias and improve patient outcomes. The trial will include patients over 18 years old admitted with electrical storm, while excluding those with certain severe conditions or contraindications.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old admitted to an intensive care unit with a diagnosis of electrical storm.
Not a fit: Patients experiencing refractory shock unrelated to ventricular arrhythmias or those with severe cardiogenic shock may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of patients with recurrent ventricular arrhythmias, potentially reducing mortality rates associated with electrical storm.
How similar studies have performed: Previous studies have indicated that dexmedetomidine may reduce arrhythmia events in ICU settings, suggesting potential success for this approach, although its use in electrical storm is less established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- All patients admitted to an intensive care unit with electrical storm over the age of 18 years will be approached for enrollment. Exclusion Criteria: * 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
Where this trial is running
Ottawa, Ontario
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (RECRUITING)
Study contacts
- Study coordinator: F. Daniel Ramirez, MD MSc
- Email: dramirez@ottawaheart.ca
- Phone: 613-696-7402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ventricular Tachycardia, Ventricular Arrhythmias, Ventricular Fibrillation, Recurrent Ventricular Tachycardia, Electrical Storm, Dexmedetomidine, Ventricular Electrical Storm, Precedex