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

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

Purpose

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

Condition	Intervention
Ventricular Fibrillation During Cardiac Surgery	Drug: lidocaine Drug: amiodarone Drug: placebo

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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: 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:

Our primary outcome will be the incidence of ventricular fibrillation requiring defibrillation during the 60 minute period following myocardial reperfusion [ Time Frame: 60 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

incidence of arrhythmias other than ventricular fibrillation, number of defibrillation attempts required, highest dose of energy and current required for defibrillation, [ Time Frame: daily ] [ Designated as safety issue: No ]

Estimated Enrollment:	360
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator saline	Drug: placebo saline
2: Active Comparator	Drug: lidocaine 1.5 mg/kg
3: Active Comparator	Drug: amiodarone 300 mg

Eligibility

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

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

Contacts and Locations

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

Contacts

Contact: William J Mauermann, MD

507/255-4240

mauermann.william@mayo.edu

Locations

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

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

William J Mauermann, MD

clinical instructor

More Information

No publications provided

Responsible Party:	Mayo clinic ( William J. Mauermann, MD )
Study ID Numbers:	06-005522, 06-005522
Study First Received:	December 21, 2007
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00587483 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Vasodilator Agents
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Lidocaine
Central Nervous System Depressants
Anesthetics
Enzyme Inhibitors
Cardiovascular Agents
Anesthetics, Local
Amiodarone

Pharmacologic Actions
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Cardiovascular Diseases
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Central Nervous System Agents
Ventricular Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010