Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation

Study Overview
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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.

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.

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

Conditions
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Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Amiodarone
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine 1.5 mg /kg<br>Lidocaine is a class I (sodium channel block) antiarrhythmic drug. | Drug: Lidocaine<br>* Lidocaine is a class I (sodium channel block) antiarrhythmic drug<br>* Other names: lidocaine hydrochloride;|
| Active Comparator: Amiodarone 300 mg<br>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. | Drug: Amiodarone<br>* 300 mg<br>* Other names: Pacerone;|
| Placebo Comparator: placebo (saline)<br> | Drug: Placebo<br>* Saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Defibrillation Attempts |  | 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. | 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. | 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. | Participants were followed from randomization until time to discharge from the hospital. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ventricular fibrillation, cardiopulmonary bypass, reperfusion ventricular fibrillation, amiodarone, lidocaine, cardiac surgery