Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation

Mayo Clinic342 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

342

Conditions

Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Participants were followed from randomization through the 60 minute period following myocardial reperfusion.

Secondary Outcomes

Number of Defibrillation Attempts

Time frame: Participants were followed from randomization through the 60 minute period following myocardial reperfusion.

Incidence of Arrhythmias Other Than Ventricular Fibrillation

Number of participants per arm who experienced arrhythmias other than ventricular fibrillation while in the ICU.

Time frame: Participants were followed from randomization through the 60 minute period following myocardial reperfusion.

Incidence of Arrhythmias in the Post-Operative Period

Number of participants per arm who experienced arrhythmias while on floor care following dismissal from the ICU.

Time frame: Participants were followed from dismissal from the ICU until dismissal from the hospital.

Use of Vasopressors

Number of participants per arm who required the use of vasopressors in the post-operative period.

Time frame: Participants were followed from randomization until time to discharge from the hospital.

Time to Discharge From the Intensive Care Unit

Time frame: 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

Time frame: Participants were followed from the date of randomization until the date of discharge from the hospital, assessed up to 60 days.

Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes