Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2010

Detailed 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.

Interventions

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

Arms, Groups and Cohorts

  • 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)

Clinical Trial Outcome Measures

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.

Secondary Measures

  • 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
    • Time Frame: Participants were followed from randomization through the 60 minute period following myocardial reperfusion.
    • Number of participants per arm who experienced arrhythmias other than ventricular fibrillation while in the ICU.
  • Incidence of Arrhythmias in the Post-Operative Period
    • Time Frame: Participants were followed from dismissal from the ICU until dismissal from the hospital.
    • Number of participants per arm who experienced arrhythmias while on floor care following dismissal from the ICU.
  • Use of Vasopressors
    • Time Frame: Participants were followed from randomization until time to discharge from the hospital.
    • Number of participants per arm who required the use of vasopressors in the post-operative period.
  • 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.

Participating in This Clinical Trial

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: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • William J. Mauermann, MD, Mayo clinic
  • Overall Official(s)
    • William J Mauermann, MD, Principal Investigator, clinical instructor

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