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Completed

NCT Number: NCT00587483

Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation

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.

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Key information

Conditions

Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

Lidocaine is a class I (sodium channel block) antiarrhythmic drug

Other names: lidocaine cardioplegia, Xylocaine, lidocaine hydrochloride

Amiodarone

Drug

300 mg

Other names: Cordarone, Pacerone

Placebo

Drug

Saline

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of Defibrillation Attempts

    Time frame: Participants were followed from randomization through the 60 minute period following myocardial reperfusion.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jan 7, 2008
Registry last updated
Aug 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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