Dexmedetomidine for Ventricular Arrhythmia (SEDATE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Ottawa Heart Institute Research Corporation
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have taken dexmedetomidine or clonidine in the 24 hours before the trial, you cannot participate.
Is Dexmedetomidine generally safe for humans?
Dexmedetomidine, also known as Precedex, is generally considered safe for use in humans, but like any drug, it can have side effects. It is important to monitor for adverse drug events (unwanted effects from taking a drug), which can affect the nervous, cardiovascular, and respiratory systems. Always consult with a healthcare provider for personalized advice.
12345What makes the drug Dexmedetomidine unique for treating ventricular arrhythmia?
Dexmedetomidine is unique because it is an alpha-2 adrenergic agonist that provides sedation and pain relief without causing respiratory depression, which is different from many other sedatives. It is typically used for sedation in various medical settings, and its application for ventricular arrhythmia may offer a novel approach compared to standard treatments.
678910Eligibility Criteria
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.Exclusion Criteria
I have had shock requiring multiple medications to maintain blood pressure.
I am experiencing severe heart failure.
I have had a cardiac arrest with no or low blood flow for over 10 minutes.
I had a heart attack that caused irregular heartbeats due to blocked blood flow.
My heart beats very slowly or irregularly, and I don't have a pacemaker.
I have taken dexmedetomidine or clonidine in the last 24 hours.
Participant Groups
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.
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.
Dexmedetomidine is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Precedex for:
- Sedation in intensive care settings
- Procedural sedation
🇺🇸 Approved in United States as Precedex for:
- Sedation in intensive care settings
- Procedural sedation
🇨🇦 Approved in Canada as Precedex for:
- Sedation in intensive care settings
- Procedural sedation
🇯🇵 Approved in Japan as Precedex for:
- Sedation in intensive care settings
- Procedural sedation
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of Ottawa Heart InstituteOttawa, Canada
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Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
References
MetaADEDB 2.0: a comprehensive database on adverse drug events. [2021]MetaADEDB is an online database we developed to integrate comprehensive information on adverse drug events (ADEs). The first version of MetaADEDB was released in 2013 and has been widely used by researchers. However, it has not been updated for more than seven years. Here, we reported its second version by collecting more and newer data from the U.S. FDA Adverse Event Reporting System (FAERS) and Canada Vigilance Adverse Reaction Online Database, in addition to the original three sources. The new version consists of 744 709 drug-ADE associations between 8498 drugs and 13 193 ADEs, which has an over 40% increase in drug-ADE associations compared to the previous version. Meanwhile, we developed a new and user-friendly web interface for data search and analysis. We hope that MetaADEDB 2.0 could provide a useful tool for drug safety assessment and related studies in drug discovery and development.
Potential risks and prevention, Part 4: Reports of significant adverse drug events. [2019]A summary analysis of three descriptive studies of significant adverse drug events (ADEs) was conducted. Case reports of ADEs published in Clin-Alert during 1976-97 were the source of information on ADEs, including drug-induced deaths, disabilities, and threats to life. The results of the three studies were compared, and recommendations were made. During the 21-year period, 1520 significant ADEs were reported (29% resulting in death, 15% in permanent disability, and 56% in life threats). Event types were distributed as adverse drug reactions (52%), allergic drug reactions (25%), medication errors (15%), and drug interactions (8%). Only 12% of the drug interactions were classified as having highest significance by one drug information reference, while 32% of the drug interactions were unclassified. Typically, patients were 40-69 years old and relatively healthy or only moderately ill and had received usual dosages. However, 29% of the patients with a drug-induced permanent disability were less than 10 years old. Only 17% of the drugs that could have been monitored by blood level tests were so monitored. The drug categories most commonly involved in ADEs were central-nervous-system agents, antimicrobials, antineoplastics, and cardiovascular agents. The nervous, hematopoietic, cardiovascular, and respiratory systems were affected the most. Faulty prescribing was the most common reason for medication error, and wrong dosage was the most common type of error. A lawsuit was reported in 13% of the cases. Overall, 52% of the cases were judged to have been preventable; of these, 50% could have been prevented by a pharmacist. Litigation was reported for 13% of the cases; settlements and judgments averaged $3.1 million. A summary analysis of more than 1500 published case reports of ADEs for 1976-97 yielded information on possible risk factors for drug-related deaths, disabilities, and life threats and on which events may have been preventable.
A tale of two citizens: a State Attorney General and a hematologist facilitate translation of research into US Food and Drug Administration actions--a SONAR report. [2021]Pharmaceutical safety is a public health issue. In 2005, the Connecticut Attorney General (AG) raised concerns over adverse drug reactions in off-label settings, noting that thalidomide was approved to treat a rare illness, but more than 90% of its use was off label. A hematologist had reported thalidomide with doxorubicin or dexamethasone was associated with venous thromboembolism (VTE) rates of 25%. We review US Food and Drug Administration (FDA) and manufacturer responses to a citizen petition filed to address these thalidomide safety issues.
Detection and reporting of drug-induced proarrhythmias: room for improvement. [2013]Recently adopted guidelines mandate the inclusion of detailed non-clinical and clinical QT data in future drug labels. As a result of increasing recognition of drug-induced proarrhythmias, and the bias introduced by the prescribing physician's awareness of these events, it is likely that the number of adverse drug reaction (ADR) reports of life-threatening ventricular arrhythmias and sudden death, allegedly caused by the drug, will increase. To illustrate how different approaches have been used to assess proarrhythmic liability and validate ADR reports on serious ventricular arrhythmias, this overview assesses pharmacoepidemiology studies on terfenadine and cisapride, the quality of ADR reports and the effect of label changes on prescribing patterns and other information to prescribing physicians. Clinical and pharmacoepidemiology studies, which in most cases did not demonstrate an increased risk for proarrhythmias with these two drugs, are discussed with emphasis on limitations, studied endpoints, and populations. Recommendations are made on how to improve the effectiveness of labelled precautions and contraindications, which may include the implementation of more effective alert systems. Given the low incidence of drug-induced proarrhythmias, 'signal' generation through ADR reports will continue to have a key role for early identification of proarrhythmic liability of newly marketed drugs. The quality of these reports varies widely, and can be improved through implementation of procedures by which complementary information is captured and events are adjudicated and classified into confidence categories using a consistent scheme across different classes of drugs.
Drug-induced torsades de pointes: Disproportionality analysis of the United States Food and Drug Administration adverse event reporting system. [2022]This study aimed to identify the most common and top drugs associated with the risk of torsades de pointes (TdP) based on the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database.
[Feasibility and Safety of Dexmedetomidine Sedation in Transarterial Embolization for Hepatocellular Carcinoma with Hepatitis C-Related Cirrhosis]. [2015]Dexmedetomidine (Precedex®)is an agonist of a2-adrenergic receptors in certain parts of the brain. It was approved for "procedural sedation in the non-intubation in under local anesthesia" in June 2013 in Japan. However, because of metabolism delay, dexmedetomidine has to be administered carefully to patients with liver dysfunction.
Dexmedetomidine as an adjuvant analgesic for intractable cancer pain. [2013]Abstract Dexmedetomidine (Precedex®) is an alpha-2 adrenergic agonist that can produce sedation and analgesia without causing respiratory depression. Its use has been described in patients undergoing mechanical ventilation, sedation for surgical and nonsurgical procedures, and prevention of withdrawal. We describe its use as an adjuvant analgesic in a patient with cancer pain refractory to multiple treatment modalities.
Dexmedetomidine: a guide to its use for sedation in the US. [2022]Intravenous dexmedetomidine (Precedex(®)) provides both effective sedation in mechanically ventilated patients in an intensive care setting and effective procedural sedation. In these patient populations, it reduces the need for rescue sedation with intravenous propofol or intravenous midazolam and reduces opioid requirements. In addition, patients receiving dexmedetomidine are calm and easy to arouse and manage. Intravenous dexmedetomidine is generally well tolerated and is not associated with respiratory depression. Although the utilization of dexmedetomidine is associated with hypotension and bradycardia, both usually resolve without intervention.
Dexmedetomidine as the primary sedative agent for brain radiation therapy in a 21-month old child. [2013]Dexmedetomidine (Precedex is an alpha2 adrenoceptor agonist which is gaining popularity as a sedative and anesthetic adjuvant. In this case report, dexmedetomidine was used safely and easily to provide sedation for 12 radiation-therapy sessions in a pediatric patient. It provided smooth induction and fast recovery with minimal respiratory depression.
Dexmedetomidine related cardiac arrest in a patient with permanent pacemaker; a cautionary tale. [2013]Dexmedetomidine (Precedex), an alpha-2 adrenergic receptor agonist is frequently and safely used as sedative agent during surgical procedures. We report a case of a 76-year-old woman who developed cardiac arrest from the use of dexmedetomidine during pacemaker lead extraction procedure.