Repeated Amiodarone Dosing In Cardiac surgicaL Procedures

Phase 4TerminatedNCT05004077

Kevin W Hatton, MD, PhD3 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation

Interventions

AMIODARONEDRUG

Assess the effectiveness of different dosing strategies of amiodarone.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Kentucky Medical Center

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

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.

Time frame: 24-hours after receiving amiodarone bolus

Secondary Outcomes

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

Time frame: 24-hours after receiving amiodarone bolus

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

Time frame: 24-hours after receiving amiodarone bolus

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

Time frame: duration of ICU and hospital visit, up to 20 days

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

Time frame: duration of ICU and hospital visit, up to 20 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.