Repeated Amiodarone Dosing In Cardiac surgicaL Procedures

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This study is a single-center, prospective, randomized, open-label trial of subjects who develop atrial fibrillation after non-emergent cardiac surgery at the University of Kentucky Chandler Medical Center (UKCMC). Patients will be randomized to receive either a conventional amiodarone dosing regimen (CDR) or a repeated amiodarone bolus dosing regimen (RBDR).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kevin Hatton
• Treatments: Amiodarone

Criteria

Inclusion Criteria:

• Subject must be 18 years old or older

• Subject must be willing to give written informed consent

• 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

Exclusion Criteria:

• Documented allergy to amiodarone or iodine

• History of atrial fibrillation or other heart conduction system abnormality

• History of cardiac maze, pulmonary vein isolation, or other procedure affecting the conduction system

• Scheduled cardiac maze, pulmonary vein isolation, or other procedure affecting the conduction system

• Low cardiac index or cardiogenic shock requiring pharmacologic or mechanical support

• History of pre-existing respiratory system disease requiring oxygen therapy prior to admission

• History of cirrhosis or other chronic liver diseases

• Pregnancy or breastfeeding mothers

• Prisoner status