Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587483
First received: December 21, 2007
Last updated: August 9, 2011
Last verified: July 2011

December 21, 2007
August 9, 2011
November 2007
January 2010   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00587483 on ClinicalTrials.gov Archive Site
  • 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 ]
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 ]
Not Provided
Not Provided
 
Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery
  • Drug: Lidocaine
    Lidocaine is a class I (sodium channel block) antiarrhythmic drug
    Other Names:
    • lidocaine cardioplegia
    • Xylocaine
    • lidocaine hydrochloride
  • Drug: Amiodarone
    300 mg
    Other Names:
    • Cordarone
    • Pacerone
  • Drug: Placebo
    Saline
  • Active Comparator: Lidocaine 1.5 mg /kg
    Lidocaine is a class I (sodium channel block) antiarrhythmic drug.
    Intervention: Drug: Lidocaine
  • 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.
    Intervention: Drug: Amiodarone
  • Placebo Comparator: placebo (saline)
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
342
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00587483
06-005522, 06-005522
No
William J. Mauermann, MD, Mayo clinic
Mayo Clinic
Not Provided
Principal Investigator: William J Mauermann, MD clinical instructor
Mayo Clinic
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP