N/A
N=342
Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation
Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery
Bottom Line
View on ClinicalTrials.gov: NCT00587483 ↗Enrolled (actual)
342
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Participants Experiencing Ventricular Fibrillation Requiring Defibrillation During the 60 Minute Period Following Myocardial Reperfusion — 66; 60; 70 Participants — p=0.427
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lidocaine (Drug); Amiodarone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Experiencing Ventricular Fibrillation Requiring Defibrillation During the 60 Minute Period Following Myocardial Reperfusion |
66; 60; 70 | 0.427 |
| SECONDARY Number of Defibrillation Attempts |
46; 57; 40; 53; 43; 46 | 0.215 |
| SECONDARY Incidence of Arrhythmias Other Than Ventricular Fibrillation |
3; 2; 0; 21; 23; 18 | — |
| SECONDARY Incidence of Arrhythmias in the Post-Operative Period |
2; 2; 3; 56; 49; 38 | — |
| SECONDARY Use of Vasopressors |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY Time to Discharge From the Intensive Care Unit |
1.357; 5.329; 4.847 | — |
| SECONDARY Time to Discharge From the Hospital |
6.183; 7.5; 9.423 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00587483). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.