Repeated Amiodarone Dosing In Cardiac surgicaL Procedures
Stopped early · Phase 4
Conditions studied: Atrial Fibrillation
In brief
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).
Key facts
- Study ID
- NCT05004077
- Run by
- Kevin W Hatton, MD, PhD
- People needed
- 3
- Starts
- 2021-11-02
- Expected to finish
- 2022-10-10
- Last updated by the study team
- 2023-11-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Kentucky Medical Center — Lexington, Kentucky, United States
Full record on ClinicalTrials.gov
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