- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00724581
Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer (PASCART)
Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer: A Controlled, Randomized, Double Blinded Trial
Patients undergoing lung resection due to pulmonary cancer can be compromised in their postoperative period due to atrial fibrillation.
A retrospective analysis performed at our institution indicates that 30 % of the population develope atrial fibrillation in the postoperative period.
Amiodarone is known to diminish the occurence of postoperative atrial fibrillation after heart surgery, why this drug is chosen as a prophylactic agent for the mentioned population.
Amiodarone is administrated twice a day for 5 days at a dose of 600 mg oral treatment after an initial loading bolus og 300 mg intravenously.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Lars R Zebis, MD
- Phone Number: +45 89495566
- Email: lrz@post.tele.dk
Study Contact Backup
- Name: Thomas Decker, MD
- Phone Number: +45 89495566
Study Locations
-
-
-
Aarhus, Denmark, DK-8200
- Aarhus University Hospital, Skejby
-
Contact:
- Lars R Zebis, MD, Ph.D.
- Phone Number: +45 89495566
- Email: lrz@post.tele.dk
-
Contact:
- Thomas D Christensen, MD, Ph.D.
- Phone Number: +45 89495566
-
Principal Investigator:
- Lars R Zebis, MD, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Resection of the lung due to confirmed diagnosis of cancer pulmones.
- Elective operation (scheduled operation for at least one day)
- Ready to be randomized
- Patient must be at least 18 at time of operation
Exclusion Criteria:
- Former operation of the lung
- Former heart surgery
- Bradycardia below 40 beats/ min
- Hypotension with systolic blood pressure below 80 mmHg
- AV-blockage of any degree or sick sinus node
- QTc interval above 440 ms for men or above 460 ms for women
- Paroxysmal, persistent or permanent atrial fibrillation or flutter
- Former atrial fibrillation or flutter for more than a month.
- Pregnant or positive pregnancy test
- Breastfeeding
- ALAT of more than twice the normal over limit
- Treatment with monoamineoxidase inhibitors (MAOI)
- Allergy to one or more components in amiodarone
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
|
intravenous bolus of 300 mg oral treatment og 600 mg twice a day for five days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Free of atrial fibrillation
Time Frame: 31082009
|
31082009
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cost-benefit analysis of amiodarone prophylactic
Time Frame: 31082009
|
31082009
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lars R Zebis, MD, Ph.D., Aarhus University Hospital Skejby
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Arrhythmias, Cardiac
- Atrial Fibrillation
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Vasodilator Agents
- Enzyme Inhibitors
- Membrane Transport Modulators
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Sodium Channel Blockers
- Cytochrome P-450 CYP2D6 Inhibitors
- Cytochrome P-450 CYP1A2 Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- Potassium Channel Blockers
- Amiodarone
Other Study ID Numbers
- 2612-3681
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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