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Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation

NCT00587483 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2011-08-11

Study results available
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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.

Conditions

  • Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery

Interventions

DRUG

Lidocaine

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

DRUG

Amiodarone

300 mg

DRUG

Placebo

Saline

Sponsors & Collaborators

Principal Investigators

  • William J Mauermann, MD · clinical instructor

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00587483 on ClinicalTrials.gov