Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation - Full Text View

Sponsor:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00587483

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.

Condition	Intervention
Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery	Drug: Lidocaine Drug: Amiodarone Drug: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	The Use of Amiodarone vs. Lidocaine and Placebo for the Prevention of Ventricular Fibrillation After Myocardial Reperfusion During Cardiopulmonary Bypass

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia Heart Surgery

Drug Information available for: Amiodarone hydrochloride Amidox Lidocaine Amiodarone

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Participants Experiencing Ventricular Fibrillation Requiring Defibrillation During the 60 Minute Period Following Myocardial Reperfusion [ Time Frame: Participants were followed from randomization through the 60 minute period following myocardial reperfusion. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of Defibrillation Attempts [ Time Frame: Participants were followed from randomization through the 60 minute period following myocardial reperfusion. ] [ Designated as safety issue: No ]
Incidence of Arrhythmias Other Than Ventricular Fibrillation [ Time Frame: Participants were followed from randomization through the 60 minute period following myocardial reperfusion. ] [ Designated as safety issue: No ]
Number of participants per arm who experienced arrhythmias other than ventricular fibrillation while in the ICU.
Incidence of Arrhythmias in the Post-Operative Period [ Time Frame: Participants were followed from dismissal from the ICU until dismissal from the hospital. ] [ Designated as safety issue: No ]
Number of participants per arm who experienced arrhythmias while on floor care following dismissal from the ICU.
Use of Vasopressors [ Time Frame: Participants were followed from randomization until time to discharge from the hospital. ] [ Designated as safety issue: No ]
Number of participants per arm who required the use of vasopressors in the post-operative period.
Time to Discharge From the Intensive Care Unit [ Time Frame: Participants were followed from the date of randomization until the date of discharge from the Intensive Care Unit, assessed up to 40 days. ] [ Designated as safety issue: No ]
Time to Discharge From the Hospital [ Time Frame: Participants were followed from the date of randomization until the date of discharge from the hospital, assessed up to 60 days. ] [ Designated as safety issue: No ]

Enrollment:	342
Study Start Date:	November 2007
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Lidocaine 1.5 mg /kg Lidocaine is a class I (sodium channel block) antiarrhythmic drug.	Drug: Lidocaine Lidocaine is a class I (sodium channel block) antiarrhythmic drug Other Names: lidocaine cardioplegia Xylocaine lidocaine hydrochloride
Active Comparator: Amiodarone 300 mg Amiodarone is used to treat and prevent certain types of serious, life-threatening ventricular arrhythmias (a certain type of abnormal heart rhythm) when other medications did not help or could not be tolerated. Amiodarone is in a class of medications called antiarrhythmics. It works by relaxing overactive heart muscles.	Drug: Amiodarone 300 mg Other Names: Cordarone Pacerone
Placebo Comparator: placebo (saline)	Drug: Placebo Saline

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587483

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

William J Mauermann, MD

clinical instructor

More Information

Additional Information:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	William J. Mauermann, MD, Mayo clinic
ClinicalTrials.gov Identifier:	NCT00587483 History of Changes
Other Study ID Numbers:	06-005522, 06-005522
Study First Received:	December 21, 2007
Results First Received:	July 13, 2011
Last Updated:	August 9, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

cardiopulmonary bypass
reperfusion ventricular fibrillation
ventricular fibrillation

amiodarone
lidocaine
cardiac surgery

Additional relevant MeSH terms:

Ventricular Fibrillation
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Amiodarone
Anti-Arrhythmia Agents
Lidocaine
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012