Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation

Condition(s) targeted: Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery

Intervention: Lidocaine (Drug); Amiodarone (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
William J Mauermann, MD, Principal Investigator, Affiliation: clinical instructor

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.

Official title: The Use of Amiodarone vs. Lidocaine and Placebo for the Prevention of Ventricular Fibrillation After Myocardial Reperfusion During Cardiopulmonary Bypass

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Participants Experiencing Ventricular Fibrillation Requiring Defibrillation During the 60 Minute Period Following Myocardial Reperfusion

Secondary outcome:

Number of Defibrillation Attempts

Incidence of Arrhythmias Other Than Ventricular Fibrillation

Incidence of Arrhythmias in the Post-Operative Period

Use of Vasopressors

Time to Discharge From the Intensive Care Unit

Time to Discharge From the Hospital

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Mayo Clinic, Rochester, Minnesota 55905, United States

Mayo Clinic Clinical Trials

Starting date: November 2007
Last updated: August 9, 2011