Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation

Completed · Not applicable · Has a placebo group

Conditions studied: Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery

In brief

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.

Key facts

Study ID

NCT00587483

Run by

Mayo Clinic

People needed

342

Starts

2007-11-01

Expected to finish

2010-01-01

Last updated by the study team

2011-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing cardiac surgery that was expected to include cross-clamping of the aorta

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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