Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation

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

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.

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. ]

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.