Repeated Amiodarone Dosing In Cardiac surgicaL Procedures

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    150
  • sponsor
    Kevin Hatton
Updated on 10 October 2021
fibrillation
amiodarone

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).

Description

This study will screen and consent approximately 150 patients undergoing non-emergent cardiac surgery. Approximately 60 of these patients are likely to develop stable postoperative atrial fibrillation (POAF) in the postoperative period. Amiodarone is commonly given as an initial intravenous (IV) bolus (150 mg IV) followed by a combined IV and oral load to a total dose of 8 gm. Because of amiodarone's beta-blocker activity, the IV bolus in patients with POAF is associated with a reduced heart rate that may lead to restoration of NSR. For this reason, some clinicians will provide up to 5 additional IV amiodarone boluses during the drug's loading period to treat RVR.

Details
Condition Arrhythmia, Atrial Fibrillation
Treatment Amiodarone
Clinical Study IdentifierNCT05004077
SponsorKevin Hatton
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

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
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