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Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation

Primary Purpose

Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lidocaine
Amiodarone
Placebo
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery focused on measuring cardiopulmonary bypass, reperfusion ventricular fibrillation, ventricular fibrillation, amiodarone, lidocaine, cardiac surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Lidocaine 1.5 mg /kg

Amiodarone 300 mg

placebo (saline)

Arm Description

Lidocaine is a class I (sodium channel block) antiarrhythmic drug.

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.

Outcomes

Primary Outcome Measures

Participants Experiencing Ventricular Fibrillation Requiring Defibrillation During the 60 Minute Period Following Myocardial Reperfusion

Secondary Outcome Measures

Number of Defibrillation Attempts
Incidence of Arrhythmias Other Than Ventricular Fibrillation
Number of participants per arm who experienced arrhythmias other than ventricular fibrillation while in the ICU.
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.
Use of Vasopressors
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 to Discharge From the Hospital

Full Information

First Posted
December 21, 2007
Last Updated
August 9, 2011
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00587483
Brief Title
Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation
Official Title
The Use of Amiodarone vs. Lidocaine and Placebo for the Prevention of Ventricular Fibrillation After Myocardial Reperfusion During Cardiopulmonary Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery
Keywords
cardiopulmonary bypass, reperfusion ventricular fibrillation, ventricular fibrillation, amiodarone, lidocaine, cardiac surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
342 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine 1.5 mg /kg
Arm Type
Active Comparator
Arm Description
Lidocaine is a class I (sodium channel block) antiarrhythmic drug.
Arm Title
Amiodarone 300 mg
Arm Type
Active Comparator
Arm Description
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.
Arm Title
placebo (saline)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
lidocaine cardioplegia, Xylocaine, lidocaine hydrochloride
Intervention Description
Lidocaine is a class I (sodium channel block) antiarrhythmic drug
Intervention Type
Drug
Intervention Name(s)
Amiodarone
Other Intervention Name(s)
Cordarone, Pacerone
Intervention Description
300 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
Number of Defibrillation Attempts
Time Frame
Participants were followed from randomization through the 60 minute period following myocardial reperfusion.
Title
Incidence of Arrhythmias Other Than Ventricular Fibrillation
Description
Number of participants per arm who experienced arrhythmias other than ventricular fibrillation while in the ICU.
Time Frame
Participants were followed from randomization through the 60 minute period following myocardial reperfusion.
Title
Incidence of Arrhythmias in the Post-Operative Period
Description
Number of participants per arm who experienced arrhythmias while on floor care following dismissal from the ICU.
Time Frame
Participants were followed from dismissal from the ICU until dismissal from the hospital.
Title
Use of Vasopressors
Description
Number of participants per arm who required the use of vasopressors in the post-operative period.
Time Frame
Participants were followed from randomization until time to discharge from the hospital.
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William J Mauermann, MD
Organizational Affiliation
clinical instructor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22770549
Citation
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.
Results Reference
derived
Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials

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Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation

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