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Sedative

Dexmedetomidine for Ventricular Arrhythmia (SEDATE Trial)

Phase 3
Recruiting
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of index hospitalization - an average of 2 weeks
Awards & highlights

Summary

"This trial aims to investigate whether using the sedative drug dexmedetomidine can help patients with recurrent ventricular arrhythmias, also known as electrical storm. It will involve multiple medical centers and

Who is the study for?
This trial is for adults over 18 who are in intensive care with a condition called electrical storm, where they experience repeated episodes of dangerous heart rhythms. It's not suitable for those who may have conditions that the study excludes.Check my eligibility
What is being tested?
The study tests if dexmedetomidine, a sedative, helps patients with electrical storm when given as part of their initial treatment. Participants will be randomly assigned to receive either dexmedetomidine or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
Dexmedetomidine can cause side effects such as low blood pressure, slow heart rate, dry mouth, and drowsiness. Since it's used under close supervision in an ICU setting, any adverse effects will be carefully monitored.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had shock requiring multiple medications to maintain blood pressure.
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I am experiencing severe heart failure.
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I have had a cardiac arrest with no or low blood flow for over 10 minutes.
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I had a heart attack that caused irregular heartbeats due to blocked blood flow.
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My heart beats very slowly or irregularly, and I don't have a pacemaker.
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I have taken dexmedetomidine or clonidine in the last 24 hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of index hospitalization - an average of 2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of index hospitalization - an average of 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The is a composite of the following: 1. All-cause in-hospital death AND/OR 2. Any in-hospital ventricular arrhythmia requiring treatment after study drug initiation.
Secondary outcome measures
All-cause in-hospital death
Intubation following study drug initiation
Length of stay in hospital
+7 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: DexmedetomidineActive Control1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.

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Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
189 Previous Clinical Trials
92,129 Total Patients Enrolled
~128 spots leftby May 2027
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