Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation
Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ventricular Fibrillation During Cardiac Surgery
Intervention: lidocaine (Drug); amiodarone (Drug); placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s):
William J Mauermann, MD, Principal Investigator, Affiliation: clinical instructor
Overall contact:
William J Mauermann, MD, Phone: 507/255-4240, Email: mauermann.william@mayo.edu
Summary
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
Clinical Details
Official title: The Use of Amiodarone vs. Lidocaine and Placebo for the Prevention of Ventricular Fibrillation After Myocardial Reperfusion During Cardiopulmonary Bypass
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Our primary outcome will be the incidence of ventricular fibrillation requiring defibrillation during the 60 minute period following myocardial reperfusion
Secondary outcome: incidence of arrhythmias other than ventricular fibrillation, number of defibrillation attempts required, highest dose of energy and current required for defibrillation,
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
William J Mauermann, MD, Phone: 507/255-4240, Email: mauermann.william@mayo.edu
Mayo Clinic, Rochester, Minnesota 55905, United States; Recruiting
Additional Information
Starting date: November 2007
Ending date: December 2010
Last updated: August 3, 2009
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