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| ID | Type | Description | Link |
|---|---|---|---|
| 06-005522 | Other Identifier | Mayo Clinic Institutional Review Board |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine 1.5 mg /kg | Active Comparator | Lidocaine is a class I (sodium channel block) antiarrhythmic drug. |
|
| Amiodarone 300 mg | Active Comparator | 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. |
|
| placebo (saline) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Lidocaine is a class I (sodium channel block) antiarrhythmic drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants Experiencing Ventricular Fibrillation Requiring Defibrillation During the 60 Minute Period Following Myocardial Reperfusion | Participants were followed from randomization through the 60 minute period following myocardial reperfusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Defibrillation Attempts | Participants were followed from randomization through the 60 minute period following myocardial reperfusion. | |
| Incidence of Arrhythmias Other Than Ventricular Fibrillation | Number of participants per arm who experienced arrhythmias other than ventricular fibrillation while in the ICU. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William J Mauermann, MD | clinical instructor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22770549 | Derived | 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. |
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Adult patients presenting for cardiac surgery in which aortic cross clamping was anticipated were recruited between 11/2007 and 6/2010
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Placebo (Saline) | Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Amiodarone 300 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants Experiencing Ventricular Fibrillation Requiring Defibrillation During the 60 Minute Period Following Myocardial Reperfusion | Intention to Treat (ITT) | Posted | Number | Participants | Participants were followed from randomization through the 60 minute period following myocardial reperfusion. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William Mauermann | Mayo Clinic | 507-255-4240 | mauermann.william@mayo.edu |
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| ID | Term |
|---|---|
| D014693 | Ventricular Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000638 | Amiodarone |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Amiodarone | Drug | 300 mg |
|
|
| Placebo | Drug | Saline |
|
| Participants were followed from randomization through the 60 minute period following myocardial reperfusion. |
| Incidence of Arrhythmias in the Post-Operative Period | Number of participants per arm who experienced arrhythmias while on floor care following dismissal from the ICU. | Participants were followed from dismissal from the ICU until dismissal from the hospital. |
| Use of Vasopressors | Number of participants per arm who required the use of vasopressors in the post-operative period. | Participants were followed from randomization until time to discharge from the hospital. |
| Time to Discharge From the Intensive Care Unit | Participants were followed from the date of randomization until the date of discharge from the Intensive Care Unit, assessed up to 40 days. |
| Time to Discharge From the Hospital | Participants were followed from the date of randomization until the date of discharge from the hospital, assessed up to 60 days. |
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.
| BG002 | Placebo (Saline) | Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Type of Operation | The planned operative procedure requiring cardiopulmonary bypass with aortic cross clamping. | Number | Participants |
|
| Preoperative Medications | Participants could have received more than one preoperative medication, therefore the totals of all the medications are greater than the number of participants. | Number | Participants |
|
| History of Dysrhythmias | Number | Participants |
|
| Left Ventricular Ejection Fraction (%) | Mean | Standard Deviation | Percentage |
|
| Medical History/Comorbidities | 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. | Number | Participants |
|
| OG002 | Placebo (Saline) | Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp. |
|
|
|
| Secondary | Number of Defibrillation Attempts | Intention to Treat (IIT) | Posted | Number | Participants | Participants were followed from randomization through the 60 minute period following myocardial reperfusion. |
|
|
|
|
| Secondary | Incidence of Arrhythmias Other Than Ventricular Fibrillation | Number of participants per arm who experienced arrhythmias other than ventricular fibrillation while in the ICU. | Posted | Number | Participants | Participants were followed from randomization through the 60 minute period following myocardial reperfusion. |
|
|
|
| Secondary | Incidence of Arrhythmias in the Post-Operative Period | Number of participants per arm who experienced arrhythmias while on floor care following dismissal from the ICU. | Posted | Number | Participants | Participants were followed from dismissal from the ICU until dismissal from the hospital. |
|
|
|
| Secondary | Use of Vasopressors | Number of participants per arm who required the use of vasopressors in the post-operative period. | Posted | Number | Participants | Participants were followed from randomization until time to discharge from the hospital. |
|
|
|
| Secondary | Time to Discharge From the Intensive Care Unit | Posted | Mean | Standard Deviation | Days | Participants were followed from the date of randomization until the date of discharge from the Intensive Care Unit, assessed up to 40 days. |
|
|
|
| Secondary | Time to Discharge From the Hospital | Posted | Mean | Standard Deviation | Days | Participants were followed from the date of randomization until the date of discharge from the hospital, assessed up to 60 days. |
|
|
|
| 0 |
| 115 |
| 0 |
| 115 |
| EG001 | 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. | 0 | 115 | 0 | 115 |
| EG002 | Placebo (Saline) | Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp. | 0 | 112 | 0 | 112 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
| > 3 Attempts |
|
| Odds Ratio (OR) |
| 0.51 |
| 2-Sided |
| 95 |
| 0.32 |
| 0.84 |
| No |
| Superiority or Other |
| Regression, Logistic | 0.424 | Odds Ratio (OR) | 0.82 | 2-Sided | 95 | 0.52 | 1.33 | No | Superiority or Other |
|
| Other arrhythmias |
|
|
| Other arrhythmias |
|
| Title | Measurements |
|---|---|
|
| Vasopressin |
|