Trial · NCT00587483
Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation
NCT00587483, Not applicable, Completed, Mayo Clinic; results first posted 2011-08-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation. Trials, record NCT00587483. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00587483
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation
- NCT number
- NCT00587483
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 342 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery
- Interventions
- Lidocaine, Amiodarone, Placebo
- First posted
- 2008-01-07
- Last updated
- 2011-08-11
- Results first posted
- 2011-08-09
- Limitations and caveats
Included a heterogeneous group of operations which possibly make our results applicable to real world perioperative care; dosing of amiodarone was higher than in previous investigations, but the dose may not have been large enough.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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. | |
| Secondary | Number of Defibrillation Attempts | Participants were followed from randomization through the 60 minute period following myocardial reperfusion. | |
| Secondary | Incidence of Arrhythmias Other Than Ventricular Fibrillation | Participants were followed from randomization through the 60 minute period following myocardial reperfusion. | Number of participants per arm who experienced arrhythmias other than ventricular fibrillation while in the ICU. |
| Secondary | Incidence of Arrhythmias in the Post-Operative Period | Participants were followed from dismissal from the ICU until dismissal from the hospital. | Number of participants per arm who experienced arrhythmias while on floor care following dismissal from the ICU. |
| Secondary | Use of Vasopressors | Participants were followed from randomization until time to discharge from the hospital. | Number of participants per arm who required the use of vasopressors in the post-operative period. |
| 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. | |
| 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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. | Intention to Treat (ITT) | Participants | NUMBER |
| SECONDARY | Number of Defibrillation Attempts | Participants were followed from randomization through the 60 minute period following myocardial reperfusion. | Intention to Treat (IIT) | Participants | NUMBER |
| SECONDARY | Incidence of Arrhythmias Other Than Ventricular Fibrillation | Participants were followed from randomization through the 60 minute period following myocardial reperfusion. | Participants | NUMBER | |
| SECONDARY | Incidence of Arrhythmias in the Post-Operative Period | Participants were followed from dismissal from the ICU until dismissal from the hospital. | Participants | NUMBER | |
| SECONDARY | Use of Vasopressors | Participants were followed from randomization until time to discharge from the hospital. | Participants | NUMBER | |
| 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. | Days | MEAN | |
| 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. | Days | MEAN |
Source ClinicalTrials.gov
Results by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants Experiencing Ventricular Fibrillation Requiring Defibrillation During the 60 Minute Period Following Myocardial Reperfusion | Lidocaine 1.5 mg /kg | 66 | Participants | ||
| Participants Experiencing Ventricular Fibrillation Requiring Defibrillation During the 60 Minute Period Following Myocardial Reperfusion | Amiodarone 300 mg | 60 | Participants | ||
| Participants Experiencing Ventricular Fibrillation Requiring Defibrillation During the 60 Minute Period Following Myocardial Reperfusion | Placebo (Saline) | 70 | Participants | ||
| Number of Defibrillation Attempts | Lidocaine 1.5 mg /kg | 0 Attempts | 46 | Participants | |
| Number of Defibrillation Attempts | Amiodarone 300 mg | 0 Attempts | 57 | Participants | |
| Number of Defibrillation Attempts | Placebo (Saline) | 0 Attempts | 40 | Participants | |
| Number of Defibrillation Attempts | Lidocaine 1.5 mg /kg | 1 - 3 Attempts | 53 | Participants | |
| Number of Defibrillation Attempts | Amiodarone 300 mg | 1 - 3 Attempts | 43 | Participants | |
| Number of Defibrillation Attempts | Placebo (Saline) | 1 - 3 Attempts | 46 | Participants | |
| Number of Defibrillation Attempts | Lidocaine 1.5 mg /kg | > 3 Attempts | 16 | Participants |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lidocaine 1.5 mg /kg | 115 | |
| Overall Study | STARTED | Amiodarone 300 mg | 115 | |
| Overall Study | STARTED | Placebo (Saline) | 112 | |
| Overall Study | COMPLETED | Lidocaine 1.5 mg /kg | 115 | |
| Overall Study | COMPLETED | Amiodarone 300 mg | 115 | |
| Overall Study | COMPLETED | Placebo (Saline) | 112 | |
| Overall Study | NOT COMPLETED | Lidocaine 1.5 mg /kg | 0 | |
| Overall Study | NOT COMPLETED | Amiodarone 300 mg | 0 | |
| Overall Study | NOT COMPLETED | Placebo (Saline) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lidocaine 1.5 mg /kg | ||
| Total, all-cause mortality | Amiodarone 300 mg | ||
| Total, all-cause mortality | Placebo (Saline) | ||
| Total, other adverse events | Lidocaine 1.5 mg /kg | 0 | 115 |
| Total, other adverse events | Amiodarone 300 mg | 0 | 115 |
| Total, other adverse events | Placebo (Saline) | 0 | 112 |
| Total, serious adverse events | Lidocaine 1.5 mg /kg | 0 | 115 |
| Total, serious adverse events | Amiodarone 300 mg | 0 | 115 |
| Total, serious adverse events | Placebo (Saline) | 0 | 112 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22770549 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00587483
GET https://conductscience.org/api/trials/v1/NCT00587483/results?page=2