Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer
Information source: Aarhus University Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation
Intervention: Amiodarone (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Aarhus University Hospital Official(s) and/or principal investigator(s):
Lars R Zebis, MD, Ph.D., Principal Investigator, Affiliation: Aarhus University Hospital
Overall contact:
Lars R Zebis, MD, Phone: +45 89495566, Email: lrz@post.tele.dk
Summary
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.
Clinical Details
Official title: Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer: A Controlled, Randomized, Double Blinded Trial
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Free of atrial fibrillation
Secondary outcome: Cost-benefit analysis of amiodarone prophylactic
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Lars R Zebis, MD, Phone: +45 89495566, Email: lrz@post.tele.dk
Aarhus University Hospital, Skejby, Aarhus DK-8200, Denmark
Additional Information
Starting date: August 2008
Ending date: December 2009
Last updated: July 28, 2008
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