Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

342 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lidocaine 1.5 mg /kg

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

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

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

Amiodarone 300 mg

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.

Group Type ACTIVE_COMPARATOR

Amiodarone

Intervention Type DRUG

300 mg

placebo (saline)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline

Interventions

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Lidocaine

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

Intervention Type DRUG

Amiodarone

300 mg

Intervention Type DRUG

Placebo

Saline

Intervention Type DRUG

Other Intervention Names

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lidocaine cardioplegia Xylocaine lidocaine hydrochloride Cordarone Pacerone

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No