Other Intraoperative Cardiac Functional Disturbances During Cardiac SurgeryNCT00587483
Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation
A study testing Lidocaine and Amiodarone in people with Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery
- What is being tested?
- Lidocaine and Amiodarone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 342 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Jan 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing cardiac surgery that was expected to include cross-clamping of the aorta
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Amiodarone vs. Lidocaine and Placebo for the Prevention of Ventricular Fibrillation After Myocardial Reperfusion During Cardiopulmonary Bypass
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.
Read the 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.
- Being tested
- Lidocaine, Amiodarone, Placebo
- Keywords
- cardiopulmonary bypass, reperfusion ventricular fibrillation, ventricular fibrillation, amiodarone, lidocaine, cardiac surgery
- Medical subject headings
- Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called lidocaine cardioplegia, Xylocaine, lidocaine hydrochloride
Lidocaine is a class I (sodium channel block) antiarrhythmic drug
AmiodaroneDrug
Also called Cordarone, Pacerone
300 mg
PlaceboDrug
Saline
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine 1.5 mg /kg | Active comparator | Lidocaine is a class I (sodium channel block) antiarrhythmic drug. Receives: Drug: Lidocaine |
| 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. Receives: Drug: Amiodarone |
| placebo (saline) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Experiencing Ventricular Fibrillation Requiring Defibrillation During the 60 Minute Period Following Myocardial Reperfusion
Measured: Participants were followed from randomization through the 60 minute period following myocardial reperfusion.
Secondary outcomes (6)
Number of Defibrillation Attempts
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Participants were followed from randomization until time to discharge from the hospital.
Time to Discharge From the Intensive Care Unit
Measured: 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
Measured: Participants were followed from the date of randomization until the date of discharge from the hospital, assessed up to 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Other Intraoperative Cardiac Functional Disturbances During Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- William J Mauermann, MD, Principal investigator, clinical instructor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587483
- Sponsor's protocol ID
- 06-005522
- Other IDs
- 06-005522
- Status last verified
- Jul 2011
- First submitted
- 21 Dec 2007
- Last updated
- 11 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22770549
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Amiodarone vs. Lidocaine and Placebo for the Prevention of Ventricular Fibrillation After Myocardial Reperfusion During Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT00587483
- Acronym / sponsor ID
- 06-005522
- Keywords
- cardiopulmonary bypass, reperfusion ventricular fibrillation, ventricular fibrillation, amiodarone, lidocaine, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 7 Jan 2008 (estimated)
- Results
- Posted 9 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lidocaine 1.5 mg /kg | Active comparator | Drug: LidocaineLidocaine is a class I (sodium channel block) antiarrhythmic drug. |
| Amiodarone 300 mg | Active comparator | Drug: AmiodaroneAmiodarone 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 | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing cardiac surgery that was expected to include cross-clamping of the aorta
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineAlso: lidocaine cardioplegia, Xylocaine, lidocaine hydrochlorideLidocaine is a class I (sodium channel block) antiarrhythmic drug | Drug | Lidocaine 1.5 mg /kg |
| AmiodaroneAlso: Cordarone, Pacerone300 mg | Drug | Amiodarone 300 mg |
| PlaceboSaline | Drug | placebo (saline) |
Primary outcome
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.
6 secondary outcomes
Number of Defibrillation Attempts
Time frame: Participants were followed from randomization through the 60 minute period following myocardial reperfusion.
Incidence of Arrhythmias Other Than Ventricular Fibrillation
Time frame: Participants were followed from randomization through the 60 minute period following myocardial reperfusion.
Incidence of Arrhythmias in the Post-Operative Period
Time frame: Participants were followed from dismissal from the ICU until dismissal from the hospital.
Use of Vasopressors
Time frame: Participants were followed from randomization until time to discharge from the hospital.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22770549Mauermann 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William J Mauermann, MD principal investigator
clinical instructor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine and Amiodarone in people with Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00587483, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2011.