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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
Results First Received: July 13, 2011  
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
Condition: Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery
Interventions: Drug: Lidocaine
Drug: Amiodarone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adult patients presenting for cardiac surgery in which aortic cross clamping was anticipated were recruited between 11/2007 and 6/2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lidocaine 1.5 mg /kg Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
Amiodarone 300 mg Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
Placebo (Saline) Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.

Participant Flow:   Overall Study
    Lidocaine 1.5 mg /kg   Amiodarone 300 mg   Placebo (Saline)
STARTED   115   115   112 
COMPLETED   115   115   112 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lidocaine 1.5 mg /kg Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
Amiodarone 300 mg Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
Placebo (Saline) Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
Total Total of all reporting groups

Baseline Measures
   Lidocaine 1.5 mg /kg   Amiodarone 300 mg   Placebo (Saline)   Total 
Overall Participants Analyzed 
[Units: Participants]
 115   115   112   342 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.7  (13.9)   63.3  (13.6)   63.6  (13.0)   63.2  (13.0) 
Gender 
[Units: Participants]
       
Female   34   41   30   105 
Male   81   74   82   237 
Type of Operation [1] 
[Units: Participants]
       
Coronary Artery Bypass Grafting only   15   18   20   53 
Valve only   37   38   31   106 
Septal Myectomy   30   34   34   98 
Multiple Procedures   33   25   27   85 
[1] The planned operative procedure requiring cardiopulmonary bypass with aortic cross clamping.
Preoperative Medications [1] 
[Units: Participants]
       
Beta blocker   73   67   73   213 
ACE Inhibitor/Angiotensin Receptor Blocker (ARB)   31   43   29   103 
Statin   42   46   60   148 
Digoxin   4   7   7   18 
Amiodarone   7   5   2   14 
[1] Participants could have received more than one preoperative medication, therefore the totals of all the medications are greater than the number of participants.
History of Dysrhythmias 
[Units: Participants]
       
Atrial Fibrillation   22   23   17   62 
Atrial Flutter   2   4   1   7 
Ventricular   3   0   3   6 
Unknown or Not Reported   88   88   91   267 
Left Ventricular Ejection Fraction (%) 
[Units: Percentage]
Mean (Standard Deviation)
 62.7  (11.5)   62.7  (10.8)   62.8  (11.7)   62.75  (11) 
Medical History/Comorbidities [1] 
[Units: Participants]
       
Diabetes Mellitus   14   16   14   44 
Chronic Obstructive Pulmonary Disease (COPD)   7   3   5   15 
Hypertension   37   55   48   140 
Unknown or Not Reported   57   41   45   143 
[1] Participants could have had more than one pre-existing condition, therefore the totals may be greater or less than the total number of participants in each group.


  Outcome Measures
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1.  Primary:   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. ]

2.  Secondary:   Number of Defibrillation Attempts   [ Time Frame: Participants were followed from randomization through the 60 minute period following myocardial reperfusion. ]

3.  Secondary:   Incidence of Arrhythmias Other Than Ventricular Fibrillation   [ Time Frame: Participants were followed from randomization through the 60 minute period following myocardial reperfusion. ]

4.  Secondary:   Incidence of Arrhythmias in the Post-Operative Period   [ Time Frame: Participants were followed from dismissal from the ICU until dismissal from the hospital. ]

5.  Secondary:   Use of Vasopressors   [ Time Frame: Participants were followed from randomization until time to discharge from the hospital. ]

6.  Secondary:   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. ]

7.  Secondary:   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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Included a heterogeneous group of operations which possibly make our results applicable to “real world” perioperative care; dosing of amiodarone was higher than in previous investigations, but the dose may not have been large enough.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. William Mauermann
Organization: Mayo Clinic
phone: 507-255-4240
e-mail: mauermann.william@mayo.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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