Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation
This study has been completed.
Sponsor:
Mayo Clinic
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587483
First received: December 21, 2007
Last updated: August 9, 2011
Last verified: July 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery |
Drug: Lidocaine Drug: Amiodarone Drug: Placebo |
| 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 |
| Official Title: | The Use of Amiodarone vs. Lidocaine and Placebo for the Prevention of Ventricular Fibrillation After Myocardial Reperfusion During Cardiopulmonary Bypass |
Resource links provided by NLM:
Drug Information available for:
Lidocaine hydrochloride
Lidocaine
Amiodarone
Amiodarone hydrochloride
U.S. FDA Resources
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of Defibrillation Attempts [ Time Frame: Participants were followed from randomization through the 60 minute period following myocardial reperfusion. ] [ Designated as safety issue: No ]
- Incidence of Arrhythmias Other Than Ventricular Fibrillation [ Time Frame: Participants were followed from randomization through the 60 minute period following myocardial reperfusion. ] [ Designated as safety issue: No ]Number of participants per arm who experienced arrhythmias other than ventricular fibrillation while in the ICU.
- Incidence of Arrhythmias in the Post-Operative Period [ Time Frame: Participants were followed from dismissal from the ICU until dismissal from the hospital. ] [ Designated as safety issue: No ]Number of participants per arm who experienced arrhythmias while on floor care following dismissal from the ICU.
- Use of Vasopressors [ Time Frame: Participants were followed from randomization until time to discharge from the hospital. ] [ Designated as safety issue: No ]Number of participants per arm who required the use of vasopressors in the post-operative period.
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
| Enrollment: | 342 |
| Study Start Date: | November 2007 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Lidocaine 1.5 mg /kg
Lidocaine is a class I (sodium channel block) antiarrhythmic drug.
|
Drug: Lidocaine
Lidocaine is a class I (sodium channel block) antiarrhythmic drug
Other Names:
|
|
Active Comparator: Amiodarone 300 mg
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.
|
Drug: Amiodarone
300 mg
Other Names:
|
| Placebo Comparator: placebo (saline) |
Drug: Placebo
Saline
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients undergoing cardiac surgery that was expected to include cross-clamping of the aorta
Exclusion Criteria:
- Women wishing to become pregnant within 6 months of surgery
- Allergy to amiodarone
- History of organ dysfunction due to previous amiodarone use
- Patients who require more than mild systemic hypothermia (<32 degrees C) during cardiopulmonary bypass
- Patients who require more than one bypass run or more than one period of aortic cross-clamping
Contacts and Locations More Information
Additional Information:
No publications provided by Mayo Clinic
Additional 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 |
| Study First Received: | December 21, 2007 |
| Results First Received: | July 13, 2011 |
| Last Updated: | August 9, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
cardiopulmonary bypass reperfusion ventricular fibrillation ventricular fibrillation |
amiodarone lidocaine cardiac surgery |
Additional relevant MeSH terms:
|
Ventricular Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Amiodarone Anti-Arrhythmia Agents Lidocaine Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vasodilator Agents Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013