Repeated Amiodarone Dosing In Cardiac surgicaL Procedures

Atrial Fibrillation Clinical Trial

— RADICAL  

Official title:

Repeated Amiodarone Dosing In Cardiac surgicaL Procedures

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05004077
• Other study ID #: 67919
• Status: Terminated
• Phase: Phase 4
• Start date: November 2, 2021
• Est. completion date: October 10, 2022

Study information

• Verified date: October 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: October 10, 2022
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• AMIODARONE
Assess the effectiveness of different dosing strategies of amiodarone.

Locations

Country	Name	City	State
United States	University of Kentucky Medical Center	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Kevin W Hatton, MD, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normal Sinus Rhythm -24 HRS	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.	24-hours after receiving amiodarone bolus
Secondary	Total Target Heart Rate Time	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	24-hours after receiving amiodarone bolus
Secondary	Time to Target Heart Rate	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	24-hours after receiving amiodarone bolus
Secondary	Normal Sinus Rhythm -Hospital Index	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	duration of ICU and hospital visit, up to 20 days
Secondary	Recurrent AF	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	duration of ICU and hospital visit, up to 20 days