Repeated Amiodarone Dosing In Cardiac surgicaL Procedures

Phase 4

Terminated

Conditions: Atrial Fibrillation

Interventions: Drug: AMIODARONE

Registration Number: NCT05004077

Lead Sponsor: Kevin W Hatton, MD, PhD

Brief 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).

Detailed 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 3

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Repeated amiodarone bolus dosing regimen (RBDR)	AMIODARONE	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.
Conventional amiodarone dosing regimen (CDR)	AMIODARONE	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.

Primary Outcome Measures

Name	Time	Method
Normal Sinus Rhythm -24 HRS	24-hours after receiving amiodarone bolus	Percentage of patients who develop stable POAF after non-emergent cardiac surgery, the percentage of patients who have converted to NSR at 24-hours after receiving a repeated amiodarone bolus and loading dose regimen to the percentage of patients who have converted to NSR after a conventional amiodarone IV loading dose regimen.

Secondary Outcome Measures

Name	Time	Method
Time to Target Heart Rate	24-hours after receiving amiodarone bolus	Time to achieve target HR (HR \< 110 bpm) between patients who receive a repeated amiodarone bolus dosing regimen and those who receive a conventional amiodarone bolus dosing regimen
Total Target Heart Rate Time	24-hours after receiving amiodarone bolus	Total time, in minutes, during the first 24 hours that the patient achieves target HR (HR \< 110 bpm) between patients who receive a repeated amiodarone bolus dosing regimen and those who receive a conventional amiodarone bolus dosing regimen
Recurrent AF	duration of ICU and hospital visit, up to 20 days	Percentage of patients who have recurrent AF before ICU discharge and before hospital discharge and patients who receive a repeated amiodarone bolus dosing regimen and those who receive a conventional amiodarone bolus dosing regimen
Normal Sinus Rhythm -Hospital Index	duration of ICU and hospital visit, up to 20 days	Percentage of patients who achieve NSR by ICU discharge and hospital discharge between patients who receive a repeated amiodarone bolus dosing regimen and those who receive a conventional amiodarone bolus dosing regimen

Trial Locations

Locations (1): University of Kentucky Medical Center
🇺🇸
Lexington, Kentucky, United States
University of Kentucky Medical Center
🇺🇸Lexington, Kentucky, United States