Clinical trial NCT00587483: Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation
Official title: The Use of Amiodarone vs. Lidocaine and Placebo for the Prevention of Ventricular Fibrillation After Myocardial Reperfusion During Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery
Keywords: cardiopulmonary bypass
reperfusion ventricular fibrillation
ventricular fibrillation
amiodarone
lidocaine
cardiac surgery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-07
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility 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

Primary outcomes:
measure: Participants Experiencing Ventricular Fibrillation Requiring Defibrillation During the 60 Minute Period Following Myocardial Reperfusion
timeFrame: Participants were followed from randomization through the 60 minute period following myocardial reperfusion.
Secondary outcomes:
measure: Number of Defibrillation Attempts
timeFrame: Participants were followed from randomization through the 60 minute period following myocardial reperfusion.
measure: Incidence of Arrhythmias Other Than Ventricular Fibrillation
timeFrame: Participants were followed from randomization through the 60 minute period following myocardial reperfusion.
measure: Incidence of Arrhythmias in the Post-Operative Period
timeFrame: Participants were followed from dismissal from the ICU until dismissal from the hospital.
measure: Use of Vasopressors
timeFrame: Participants were followed from randomization until time to discharge from the hospital.
measure: Time to Discharge From the Intensive Care Unit
timeFrame: Participants were followed from the date of randomization until the date of discharge from the Intensive Care Unit, assessed up to 40 days.
measure: Time to Discharge From the Hospital
timeFrame: Participants were followed from the date of randomization until the date of discharge from the hospital, assessed up to 60 days.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: clinical instructor
name: William J Mauermann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mauermann WJ, Pulido JN, Barbara DW, Abel MD, Li Z, Meade LA, Schaff HV, White RD. Amiodarone versus lidocaine and placebo for the prevention of ventricular fibrillation after aortic crossclamping: a randomized, double-blind, placebo-controlled trial. J Thorac Cardiovasc Surg. 2012 Nov;144(5):1229-34. doi: 10.1016/j.jtcvs.2012.06.039. Epub 2012 Jul 4.