Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation

Not Applicable

Completed

Conditions: Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery

Brief Summary: This was a prospective, randomized, double blinded study in which patients undergoing a cardiopulmonary bypass (CPB) with aortic cross clamping were randomly assigned to receive amiodarone, lidocaine, or saline placebo prior to removal of the aortic cross clamp. (CPB is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body.) Specifically, we will test the hypothesis that amiodarone is superior to both lidocaine and placebo in the prevention of a severely abnormal heart rhythm when the blood flow is restored to the heart after the aortic cross clamp is removed.

Detailed Description: This was a prospective, randomized, double blinded study in which patients undergoing cardiopulmonary bypass with aortic cross clamping were randomly assigned to receive amiodarone, lidocaine, or saline placebo prior to removal of the aortic cross clamp. Specifically, we will test the hypothesis that amiodarone administration decreases the incidence of ventricular fibrillation, the number of defibrillation attempts and the total energy and current required for defibrillation should ventricular fibrillation occur.

Recruitment & Eligibility

Inclusion Criteria

Patients undergoing cardiac surgery that was expected to include cross-clamping of the aorta

Exclusion Criteria

Women wishing to become pregnant within 6 months of surgery
Allergy to amiodarone
History of organ dysfunction due to previous amiodarone use
Patients who require more than mild systemic hypothermia (<32 degrees C) during cardiopulmonary bypass
Patients who require more than one bypass run or more than one period of aortic cross-clamping

Arm && Interventions

Group	Intervention	Description
Lidocaine 1.5 mg /kg	Lidocaine	Lidocaine is a class I (sodium channel block) antiarrhythmic drug.
Amiodarone 300 mg	Amiodarone	Amiodarone is used to treat and prevent certain types of serious, life-threatening ventricular arrhythmias (a certain type of abnormal heart rhythm) when other medications did not help or could not be tolerated. Amiodarone is in a class of medications called antiarrhythmics. It works by relaxing overactive heart muscles.
placebo (saline)	Placebo	-

Primary Outcome Measures

Name	Time	Method
Participants Experiencing Ventricular Fibrillation Requiring Defibrillation During the 60 Minute Period Following Myocardial Reperfusion	Participants were followed from randomization through the 60 minute period following myocardial reperfusion.

Secondary Outcome Measures

Name	Time	Method
Number of Defibrillation Attempts	Participants were followed from randomization through the 60 minute period following myocardial reperfusion.
Incidence of Arrhythmias Other Than Ventricular Fibrillation	Participants were followed from randomization through the 60 minute period following myocardial reperfusion.	Number of participants per arm who experienced arrhythmias other than ventricular fibrillation while in the ICU.
Incidence of Arrhythmias in the Post-Operative Period	Participants were followed from dismissal from the ICU until dismissal from the hospital.	Number of participants per arm who experienced arrhythmias while on floor care following dismissal from the ICU.
Use of Vasopressors	Participants were followed from randomization until time to discharge from the hospital.	Number of participants per arm who required the use of vasopressors in the post-operative period.
Time to Discharge From the Intensive Care Unit	Participants were followed from the date of randomization until the date of discharge from the Intensive Care Unit, assessed up to 40 days.
Time to Discharge From the Hospital	Participants were followed from the date of randomization until the date of discharge from the hospital, assessed up to 60 days.