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

We propose a prospective, randomized, double blinded outcome study in which patients undergoing operative procedures requiring cardiopulmonary bypass (CPB) with aortic cross clamping will be 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 is superior to both lidocaine and saline in the prevention of reperfusion ventricular fibrillation after aortic cross clamp removal

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Study Primary Completion Date: December 2010

Intervention(s) in this Clinical Trial

• Drug: lidocaine
  • 1.5 mg/kg
• Drug: amiodarone
  • 300 mg
• Drug: placebo
  • saline

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • saline
• Active Comparator: 2
• Active Comparator: 3

Primary Measures

• Our primary outcome will be the incidence of ventricular fibrillation requiring defibrillation during the 60 minute period following myocardial reperfusion
  • Time Frame: 60 min
    Safety Issue?: No

Secondary Measures

• incidence of arrhythmias other than ventricular fibrillation, number of defibrillation attempts required, highest dose of energy and current required for defibrillation,
  • Time Frame: daily
    Safety Issue?: No

Inclusion Criteria:

• Patients between 18 and 100 years of surgery undergoing cardiac surgery

Exclusion Criteria:

• Women wishing to become preganat within 6 months of surgery

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 Sponsor: Mayo Clinic

Overall Clinical Trial Officials and Contacts

William J Mauermann, MD Principal Investigator clinical instructor  

Overall Contact: William J Mauermann, MD 507/255-4240 mauermann.william@mayo.edu

Information obtained from ClinicalTrials.gov on March 18, 2010

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