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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

Pivotal Trial

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of index hospitalization - an average of 2 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

All-cause in-hospital death

Intubation following study drug initiation

Length of stay in hospital

+7 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 6Eligibility criteria met