Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation

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

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.

Intervention(s) in this Clinical Trial

• Drug: Lidocaine
  • Lidocaine is a class I (sodium channel block) antiarrhythmic drug
• Drug: Amiodarone
  • 300 mg
• Drug: Placebo
  • Saline

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Lidocaine 1.5 mg /kg
  • Lidocaine is a class I (sodium channel block) antiarrhythmic drug.
• Active Comparator: 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.
• Placebo Comparator: placebo (saline)

Primary Measures

• 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.
    Safety Issue?: No

Secondary Measures

• Number of Defibrillation Attempts
  • Time Frame: Participants were followed from randomization through the 60 minute period following myocardial reperfusion.
    Safety Issue?: No
• Incidence of Arrhythmias Other Than Ventricular Fibrillation
  • Time Frame: Participants were followed from randomization through the 60 minute period following myocardial reperfusion.
    Safety Issue?: No
• Incidence of Arrhythmias in the Post-Operative Period
  • Time Frame: Participants were followed from dismissal from the ICU until dismissal from the hospital.
    Safety Issue?: No
• Use of Vasopressors
  • Time Frame: Participants were followed from randomization until time to discharge from the hospital.
    Safety Issue?: No
• 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.
    Safety Issue?: No
• 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.
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Mayo Clinic Other

Overall Clinical Trial Officials and Contacts

William J Mauermann, MD Principal Investigator clinical instructor  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00587483

Study ID Number: 06-005522

ClinicalTrials.gov Identifier: NCT00587483

Health Authority: United States: Institutional Review Board

Mayo Clinic Clinical Trials