Repeated Amiodarone Dosing In Cardiac surgicaL Procedures

(RADICAL Trial)

Overseen By Amy Banfield, MA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Kevin W Hatton, MD, PhD

Disqualifiers: Atrial fibrillation, Heart abnormalities, Respiratory disease, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 hours

3 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Kevin Hatton, MD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

Inclusion Criteria

Subject must undergo or scheduled for non-emergent cardiac surgery, including coronary artery bypass grafting (CABG), non-infectious valve repair or replacement, atrial or septal defect repair, thoracic aortic replacement surgery, or any combination of these procedures

Subject must be willing to give written informed consent

Exclusion Criteria

You have a history of heart rhythm issues.

You have had a heart procedure in the past that affected your heart's electrical system.

Low cardiac index or cardiogenic shock requiring pharmacologic or mechanical support

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a conventional or repeated amiodarone dosing regimen to manage postoperative atrial fibrillation

24 hours

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including heart rate and rhythm stability

up to 20 days

Regular monitoring during ICU and hospital stay

Long-term follow-up

Participants are monitored for recurrent atrial fibrillation and maintenance of normal sinus rhythm until hospital discharge

up to 20 days

What Are the Treatments Tested in This Trial?

Interventions

• Amiodarone

How Is the Trial Designed?

Group I: Repeated amiodarone bolus dosing regimen (RBDR) Active Control 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Kevin W Hatton, MD, PhD

Lead Sponsor

Trials

1

Recruited

3+

Kevin Hatton

Lead Sponsor

Trials

2

Recruited

4+