Expired Study
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Rochester, Minnesota 55905


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00587483


Primary Contact:

Principal Investigator
William J Mauermann, MD
clinical instructor


Backup Contact:

N/A


Location Contact:

Rochester, Minnesota 55905
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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