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Repeated Amiodarone Dosing In Cardiac surgicaL Procedures (RADICAL Trial)
Phase 4
Waitlist Available
Led By Kevin Hatton, MD
Research Sponsored by Kevin W Hatton, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-hours after receiving amiodarone bolus
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group
Summary
This trial is testing two ways of giving amiodarone to patients who develop an irregular heartbeat after heart surgery. The medication helps slow down the heart rate and restore normal rhythm.
Eligible Conditions
- Atrial Fibrillation
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24-hours after receiving amiodarone bolus
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-hours after receiving amiodarone bolus
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Normal Sinus Rhythm -24 HRS
Secondary study objectives
Normal Sinus Rhythm -Hospital Index
Recurrent AF
Time to Target Heart Rate
+1 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Repeated amiodarone bolus dosing regimen (RBDR)Active Control1 Intervention
Initial amiodarone bolus of 150 mg IV over 10 minutes, then 1.0 mg/min IV amiodarone infusion for 6 hours, then a 0.5 mg/min IV amiodarone infusion for 18 hours, followed by enteral (400 mg amiodarone oral or per tube three times daily or 2 times daily if the patient has gastrointestinal intolerance when taking the drug three times daily) or intravenous amiodarone (0.5 mg/min continuous infusion) to complete an 8-gm total amiodarone load. In addition, patients in the RBDR will receive an additional 150 mg IV amiodarone bolus whenever the patient develops tachycardia (Heart Rate (HR) = 110 beats per minute) lasting more than 10 minutes. This bolus may be repeated up to a total of 5 times (6 total boluses) over the first 24 hours. Maintenance amiodarone (200 mg amiodarone oral or per tube once daily) at discretion of attending physician.
Group II: Conventional amiodarone dosing regimen (CDR)Active Control1 Intervention
Initial amiodarone bolus of 150 mg IV over 10 minutes then a 24-hour amiodarone loading infusion (1 mg/min for 6 hours followed by 0.5 mg/min for 18 hours), followed by enteral (400 mg amiodarone oral or per tube three times daily or 2 times daily if the patient has gastrointestinal intolerance when taking the drug three times daily) or intravenous amiodarone (0.5 mg/min continuous infusion) to complete an 8-gm total amiodarone load. Maintenance amiodarone (200 mg amiodarone oral or per tube once daily) at discretion of attending physician.
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Who is running the clinical trial?
Kevin W Hatton, MD, PhDLead Sponsor
Kevin HattonLead Sponsor
1 Previous Clinical Trials
1 Total Patients Enrolled
Kevin Hatton, MDPrincipal Investigator - University of Kentucky
University Of Kentucky College Of Medicine (Medical School)
University Of Fl College Of Medicine (Residency)