Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation

Mayo Clinic

Status: Completed

Conditions: Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery

Treatments: Drug: Lidocaine; Drug: Amiodarone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00587483

06-005522 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 342 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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342 participants in 3 patient groups, including a placebo group

Lidocaine 1.5 mg /kg

Active Comparator group

Description:

Lidocaine is a class I (sodium channel block) antiarrhythmic drug.

Treatment:

Drug: Lidocaine

Amiodarone 300 mg

Active Comparator group

Description:

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.

Treatment:

Drug: Amiodarone

placebo (saline)

Placebo Comparator group

Treatment:

Drug: Placebo