Trial Outcomes & Findings for Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation (NCT NCT00587483)
NCT ID: NCT00587483
Last Updated: 2011-08-11
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
342 participants
Primary outcome timeframe
Participants were followed from randomization through the 60 minute period following myocardial reperfusion.
Results posted on
2011-08-11
Participant Flow
Adult patients presenting for cardiac surgery in which aortic cross clamping was anticipated were recruited between 11/2007 and 6/2010
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
115
|
115
|
112
|
|
Overall Study
COMPLETED
|
115
|
115
|
112
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation
Baseline characteristics by cohort
| Measure |
Lidocaine 1.5 mg /kg
n=115 Participants
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
n=115 Participants
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)
n=112 Participants
Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
|
Total
n=342 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
62.7 years
STANDARD_DEVIATION 13.9 • n=99 Participants
|
63.3 years
STANDARD_DEVIATION 13.6 • n=107 Participants
|
63.6 years
STANDARD_DEVIATION 13.0 • n=206 Participants
|
63.2 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
105 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
237 Participants
n=7 Participants
|
|
Type of Operation
Coronary Artery Bypass Grafting only
|
15 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
|
Type of Operation
Valve only
|
37 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
106 Participants
n=7 Participants
|
|
Type of Operation
Septal Myectomy
|
30 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
98 Participants
n=7 Participants
|
|
Type of Operation
Multiple Procedures
|
33 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
85 Participants
n=7 Participants
|
|
Preoperative Medications
Beta blocker
|
73 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
213 Participants
n=7 Participants
|
|
Preoperative Medications
ACE Inhibitor/Angiotensin Receptor Blocker (ARB)
|
31 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
103 Participants
n=7 Participants
|
|
Preoperative Medications
Statin
|
42 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
148 Participants
n=7 Participants
|
|
Preoperative Medications
Digoxin
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Preoperative Medications
Amiodarone
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
History of Dysrhythmias
Atrial Fibrillation
|
22 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
62 Participants
n=7 Participants
|
|
History of Dysrhythmias
Atrial Flutter
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
History of Dysrhythmias
Ventricular
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
History of Dysrhythmias
Unknown or Not Reported
|
88 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
267 Participants
n=7 Participants
|
|
Left Ventricular Ejection Fraction (%)
|
62.7 Percentage
STANDARD_DEVIATION 11.5 • n=99 Participants
|
62.7 Percentage
STANDARD_DEVIATION 10.8 • n=107 Participants
|
62.8 Percentage
STANDARD_DEVIATION 11.7 • n=206 Participants
|
62.75 Percentage
STANDARD_DEVIATION 11 • n=7 Participants
|
|
Medical History/Comorbidities
Diabetes Mellitus
|
14 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
|
Medical History/Comorbidities
Chronic Obstructive Pulmonary Disease (COPD)
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Medical History/Comorbidities
Hypertension
|
37 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
140 Participants
n=7 Participants
|
|
Medical History/Comorbidities
Unknown or Not Reported
|
57 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
143 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Participants were followed from randomization through the 60 minute period following myocardial reperfusion.Population: Intention to Treat (ITT)
Outcome measures
| Measure |
Lidocaine 1.5 mg /kg
n=115 Participants
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
n=115 Participants
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)
n=112 Participants
Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
|
|---|---|---|---|
|
Participants Experiencing Ventricular Fibrillation Requiring Defibrillation During the 60 Minute Period Following Myocardial Reperfusion
|
66 Participants
|
60 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: Participants were followed from randomization through the 60 minute period following myocardial reperfusion.Population: Intention to Treat (IIT)
Outcome measures
| Measure |
Lidocaine 1.5 mg /kg
n=115 Participants
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
n=115 Participants
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)
n=112 Participants
Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
|
|---|---|---|---|
|
Number of Defibrillation Attempts
0 Attempts
|
46 Participants
|
57 Participants
|
40 Participants
|
|
Number of Defibrillation Attempts
1 - 3 Attempts
|
53 Participants
|
43 Participants
|
46 Participants
|
|
Number of Defibrillation Attempts
> 3 Attempts
|
16 Participants
|
15 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Lidocaine 1.5 mg /kg
n=115 Participants
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
n=114 Participants
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)
n=111 Participants
Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
|
|---|---|---|---|
|
Incidence of Arrhythmias Other Than Ventricular Fibrillation
Ventricular tachycardia
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Incidence of Arrhythmias Other Than Ventricular Fibrillation
Atrial fibrillation
|
21 Participants
|
23 Participants
|
18 Participants
|
|
Incidence of Arrhythmias Other Than Ventricular Fibrillation
Other arrhythmias
|
27 Participants
|
35 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Lidocaine 1.5 mg /kg
n=115 Participants
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
n=114 Participants
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)
n=111 Participants
Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
|
|---|---|---|---|
|
Incidence of Arrhythmias in the Post-Operative Period
Ventricular tachycardia
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Incidence of Arrhythmias in the Post-Operative Period
Atrial fibrillation
|
56 Participants
|
49 Participants
|
38 Participants
|
|
Incidence of Arrhythmias in the Post-Operative Period
Other arrhythmias
|
36 Participants
|
42 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Lidocaine 1.5 mg /kg
n=115 Participants
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
n=114 Participants
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)
n=111 Participants
Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
|
|---|---|---|---|
|
Use of Vasopressors
Epinephrine
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Use of Vasopressors
Norepinephrine
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Use of Vasopressors
Vasopressin
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Participants were followed from the date of randomization until the date of discharge from the Intensive Care Unit, assessed up to 40 days.Outcome measures
| Measure |
Lidocaine 1.5 mg /kg
n=115 Participants
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
n=114 Participants
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)
n=111 Participants
Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
|
|---|---|---|---|
|
Time to Discharge From the Intensive Care Unit
|
1.357 Days
Standard Deviation 0.948
|
5.329 Days
Standard Deviation 34.515
|
4.847 Days
Standard Deviation 34.622
|
SECONDARY outcome
Timeframe: Participants were followed from the date of randomization until the date of discharge from the hospital, assessed up to 60 days.Outcome measures
| Measure |
Lidocaine 1.5 mg /kg
n=115 Participants
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
n=114 Participants
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)
n=111 Participants
Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
|
|---|---|---|---|
|
Time to Discharge From the Hospital
|
6.183 Days
Standard Deviation 2.833
|
7.5 Days
Standard Deviation 8.545
|
9.423 Days
Standard Deviation 34.572
|
Adverse Events
Lidocaine 1.5 mg /kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Amiodarone 300 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (Saline)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place