Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation

August 9, 2011 updated by: Mayo Clinic

The Use of Amiodarone vs. Lidocaine and Placebo for the Prevention of Ventricular Fibrillation After Myocardial Reperfusion During Cardiopulmonary Bypass

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

342

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Xylocaine
  • lidocaine hydrochloride
  • lidocaine cardioplegia
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Participants were followed from randomization through the 60 minute period following myocardial reperfusion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Defibrillation Attempts
Time Frame: Participants were followed from randomization through the 60 minute period following myocardial reperfusion.
Participants were followed from randomization through the 60 minute period following myocardial reperfusion.
Incidence of Arrhythmias Other Than Ventricular Fibrillation
Time Frame: Participants were followed from randomization through the 60 minute period following myocardial reperfusion.
Number of participants per arm who experienced arrhythmias other than ventricular fibrillation while in the ICU.
Participants were followed from randomization through the 60 minute period following myocardial reperfusion.
Incidence of Arrhythmias in the Post-Operative Period
Time Frame: Participants were followed from dismissal from the ICU until dismissal from the hospital.
Number of participants per arm who experienced arrhythmias while on floor care following dismissal from the ICU.
Participants were followed from dismissal from the ICU until dismissal from the hospital.
Use of Vasopressors
Time Frame: Participants were followed from randomization until time to discharge from the hospital.
Number of participants per arm who required the use of vasopressors in the post-operative period.
Participants were followed from randomization until time to discharge from the hospital.
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.
Participants were followed from the date of randomization until the date of discharge from the Intensive Care Unit, assessed up to 40 days.
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.
Participants were followed from the date of randomization until the date of discharge from the hospital, assessed up to 60 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: William J Mauermann, MD, Clinical Instructor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

January 4, 2008

First Posted (ESTIMATE)

January 7, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 11, 2011

Last Update Submitted That Met QC Criteria

August 9, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-005522 (OTHER: Mayo Clinic Institutional Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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