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Repeated amiodarone bolus dosing regimen (RBDR) for Atrial Fibrillation (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

RADICAL Trial Summary

This trial is testing two different ways to give amiodarone to people who develop atrial fibrillation after non-emergency cardiac surgery.

RADICAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-hours after receiving amiodarone bolus
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-hours after receiving amiodarone bolus for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Normal Sinus Rhythm -24 HRS
Secondary outcome measures
Normal Sinus Rhythm -Hospital Index
Recurrent AF
Time to Target Heart Rate
+1 more

RADICAL 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.

Find a Location

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)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what conditions is the Repeated Amiodarone Bolus Dosing Regimen (RBDR) typically utilized?

"RBDR, or repeated amiodarone bolus dosing regimen is a favoured treatment for atrial fibrillation. It has also been used to address other conditions including cardiothoracic surgery and recurrent ventricular fibrillation."

Answered by AI

What is the capacity for participants in this clinical trial?

"Affirmative. According to the information found on clinicaltrials.gov, enrollment is still open for this trial which was initially posted in November of 2021 and revised as recently as November 17th 2022. 150 individuals are required from 1 medical site location."

Answered by AI

Are there any available slots for participants in this investigation?

"Reportedly, this experiment is currently recruiting. As per clinicaltrials.gov, it was initially posted on November 2nd 2021 and its details were most recently edited on November 17th 2022."

Answered by AI

Is the administration of amiodarone via RBDR officially sanctioned by the FDA?

"The safety of Repeated amiodarone bolus dosing regimen (RBDR) was graded a 3, which is the highest score given its Phase 4 classification. This signifies that this drug has already been approved for use in medicine."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
University of Kentucky Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Repeated Amiodarone Dosing In Cardiac surgicaL Procedures
Kevin W Hatton, MD, PhD 2021. "Repeated Amiodarone Dosing In Cardiac surgicaL Procedures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05004077.
~1 spots leftby Apr 2025
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