Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery Clinical Trial
Official title:
The Use of Amiodarone vs. Lidocaine and Placebo for the Prevention of Ventricular Fibrillation After Myocardial Reperfusion During Cardiopulmonary Bypass
| Verified date | July 2011 |
| Source | Mayo Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 342 |
| Est. completion date | January 2010 |
| Est. primary completion date | January 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic | Rochester | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | No | |
| Secondary | Number of Defibrillation Attempts | Participants were followed from randomization through the 60 minute period following myocardial reperfusion. | No | |
| Secondary | Incidence of Arrhythmias Other Than Ventricular Fibrillation | Number of participants per arm who experienced arrhythmias other than ventricular fibrillation while in the ICU. | Participants were followed from randomization through the 60 minute period following myocardial reperfusion. | No |
| 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. | Participants were followed from dismissal from the ICU until dismissal from the hospital. | No |
| Secondary | 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. | No |
| Secondary | 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. | No | |
| Secondary | 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. | No |