Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00587483
Recruitment Status : Completed
First Posted : January 7, 2008
Results First Posted : August 9, 2011
Last Update Posted : August 11, 2011
Sponsor:
Information provided by:
Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery
Interventions Drug: Lidocaine
Drug: Amiodarone
Drug: Placebo
Enrollment 342
Recruitment Details Adult patients presenting for cardiac surgery in which aortic cross clamping was anticipated were recruited between 11/2007 and 6/2010
Pre-assignment Details  
Arm/Group Title Lidocaine 1.5 mg /kg Amiodarone 300 mg Placebo (Saline)
Hide Arm/Group Description Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp. 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. Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
Period Title: Overall Study
Started 115 115 112
Completed 115 115 112
Not Completed 0 0 0
Arm/Group Title Lidocaine 1.5 mg /kg Amiodarone 300 mg Placebo (Saline) Total
Hide Arm/Group Description Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp. 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. Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp. Total of all reporting groups
Overall Number of Baseline Participants 115 115 112 342
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 115 participants 115 participants 112 participants 342 participants
62.7  (13.9) 63.3  (13.6) 63.6  (13.0) 63.2  (13.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants 115 participants 112 participants 342 participants
Female
34
  29.6%
41
  35.7%
30
  26.8%
105
  30.7%
Male
81
  70.4%
74
  64.3%
82
  73.2%
237
  69.3%
Type of Operation   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 115 participants 115 participants 112 participants 342 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]
Measure Description: The planned operative procedure requiring cardiopulmonary bypass with aortic cross clamping.
Preoperative Medications   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 115 participants 115 participants 112 participants 342 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]
Measure Description: 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 115 participants 115 participants 112 participants 342 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 (%)  
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 115 participants 115 participants 112 participants 342 participants
62.7  (11.5) 62.7  (10.8) 62.8  (11.7) 62.75  (11)
Medical History/Comorbidities   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 115 participants 115 participants 112 participants 342 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]
Measure Description: 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.
1.Primary Outcome
Title Participants Experiencing Ventricular Fibrillation Requiring Defibrillation During the 60 Minute Period Following Myocardial Reperfusion
Hide Description [Not Specified]
Time Frame Participants were followed from randomization through the 60 minute period following myocardial reperfusion.
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT)
Arm/Group Title Lidocaine 1.5 mg /kg Amiodarone 300 mg Placebo (Saline)
Hide Arm/Group Description:
Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
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.
Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
Overall Number of Participants Analyzed 115 115 112
Measure Type: Number
Unit of Measure: Participants
66 60 70
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lidocaine 1.5 mg /kg, Amiodarone 300 mg
Comments The expected overall incidence of ventricular fibrillation after removal of the aortic clamp is at least 70%. Using a chi square analysis with 80% power and an alpha of 0.0167, we estimate that we will need 113 patients in each group to show a 30% reduction in the incidence of ventricular fibrillation with amiodarone.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.427
Comments An alpha of 0.0167 was used to account for multiple comparisons among the 3 groups. Given the total of 3 comparisons, 0.05/3 = 0.0167 was used in the calculation.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.48 to 1.37
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Amiodarone 300 mg, Placebo (Saline)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.117
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
0.39 to 1.11
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lidocaine 1.5 mg /kg, Placebo (Saline)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.433
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.47 to 1.37
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Defibrillation Attempts
Hide Description [Not Specified]
Time Frame Participants were followed from randomization through the 60 minute period following myocardial reperfusion.
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (IIT)
Arm/Group Title Lidocaine 1.5 mg /kg Amiodarone 300 mg Placebo (Saline)
Hide Arm/Group Description:
Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
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.
Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
Overall Number of Participants Analyzed 115 115 112
Measure Type: Number
Unit of Measure: Participants
0 Attempts 46 57 40
1 - 3 Attempts 53 43 46
> 3 Attempts 16 15 14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lidocaine 1.5 mg /kg, Amiodarone 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.215
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.45 to 1.19
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Amiodarone 300 mg, Placebo (Saline)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.51
Confidence Interval (2-Sided) 95%
0.32 to 0.84
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lidocaine 1.5 mg /kg, Placebo (Saline)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.424
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.52 to 1.33
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Incidence of Arrhythmias Other Than Ventricular Fibrillation
Hide Description Number of participants per arm who experienced arrhythmias other than ventricular fibrillation while in the ICU.
Time Frame Participants were followed from randomization through the 60 minute period following myocardial reperfusion.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine 1.5 mg /kg Amiodarone 300 mg Placebo (Saline)
Hide Arm/Group Description:
Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
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.
Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
Overall Number of Participants Analyzed 115 114 111
Measure Type: Number
Unit of Measure: Participants
Ventricular tachycardia 3 2 0
Atrial fibrillation 21 23 18
Other arrhythmias 27 35 27
4.Secondary Outcome
Title Incidence of Arrhythmias in the Post-Operative Period
Hide Description Number of participants per arm who experienced arrhythmias while on floor care following dismissal from the ICU.
Time Frame Participants were followed from dismissal from the ICU until dismissal from the hospital.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine 1.5 mg /kg Amiodarone 300 mg Placebo (Saline)
Hide Arm/Group Description:
Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
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.
Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
Overall Number of Participants Analyzed 115 114 111
Measure Type: Number
Unit of Measure: Participants
Ventricular tachycardia 2 2 3
Atrial fibrillation 56 49 38
Other arrhythmias 36 42 24
5.Secondary Outcome
Title Use of Vasopressors
Hide Description Number of participants per arm who required the use of vasopressors in the post-operative period.
Time Frame Participants were followed from randomization until time to discharge from the hospital.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine 1.5 mg /kg Amiodarone 300 mg Placebo (Saline)
Hide Arm/Group Description:
Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
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.
Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
Overall Number of Participants Analyzed 115 114 111
Measure Type: Number
Unit of Measure: Participants
Epinephrine 1 1 0
Norepinephrine 0 0 0
Vasopressin 0 2 0
6.Secondary Outcome
Title Time to Discharge From the Intensive Care Unit
Hide Description [Not Specified]
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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine 1.5 mg /kg Amiodarone 300 mg Placebo (Saline)
Hide Arm/Group Description:
Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
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.
Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
Overall Number of Participants Analyzed 115 114 111
Mean (Standard Deviation)
Unit of Measure: Days
1.357  (0.948) 5.329  (34.515) 4.847  (34.622)
7.Secondary Outcome
Title Time to Discharge From the Hospital
Hide Description [Not Specified]
Time Frame Participants were followed from the date of randomization until the date of discharge from the hospital, assessed up to 60 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine 1.5 mg /kg Amiodarone 300 mg Placebo (Saline)
Hide Arm/Group Description:
Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
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.
Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
Overall Number of Participants Analyzed 115 114 111
Mean (Standard Deviation)
Unit of Measure: Days
6.183  (2.833) 7.5  (8.545) 9.423  (34.572)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lidocaine 1.5 mg /kg Amiodarone 300 mg Placebo (Saline)
Hide Arm/Group Description Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp. 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. Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
All-Cause Mortality
Lidocaine 1.5 mg /kg Amiodarone 300 mg Placebo (Saline)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lidocaine 1.5 mg /kg Amiodarone 300 mg Placebo (Saline)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/115 (0.00%)   0/115 (0.00%)   0/112 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lidocaine 1.5 mg /kg Amiodarone 300 mg Placebo (Saline)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/115 (0.00%)   0/115 (0.00%)   0/112 (0.00%) 
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.
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
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 )
First Submitted: December 21, 2007
First Posted: January 7, 2008
Results First Submitted: July 13, 2011
Results First Posted: August 9, 2011
Last Update Posted: August 11, 2011