Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer - Full Text View

Sponsor:	Aarhus University Hospital
Information provided by:	Aarhus University Hospital
ClinicalTrials.gov Identifier:	NCT00724581

Purpose

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.

Condition	Intervention	Phase
Atrial Fibrillation	Drug: Amiodarone	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer: A Controlled, Randomized, Double Blinded Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Cancer Lung Cancer Surgery

Drug Information available for: Amiodarone hydrochloride Amidox Amiodarone

U.S. FDA Resources

Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:

Free of atrial fibrillation [ Time Frame: 31082009 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Cost-benefit analysis of amiodarone prophylactic [ Time Frame: 31082009 ] [ Designated as safety issue: No ]

Estimated Enrollment:	275
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Amiodarone intravenous bolus of 300 mg oral treatment og 600 mg twice a day for five days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724581

Contacts

Contact: Lars R Zebis, MD	+45 89495566	lrz@post.tele.dk
Contact: Thomas Decker, MD	+45 89495566

Locations

Denmark
Aarhus University Hospital, Skejby
Aarhus, Denmark, DK-8200

Sponsors and Collaborators

Aarhus University Hospital

Investigators

Principal Investigator:

Lars R Zebis, MD, Ph.D.

Aarhus University Hospital

More Information

No publications provided

Responsible Party:	Aarhus University Hospital ( Lars Riber Zebis )
Study ID Numbers:	2612-3681
Study First Received:	July 25, 2008
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00724581 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Aarhus University Hospital:

Atrial fibrillation, amiodarone

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Vasodilator Agents
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Amiodarone
Neoplasms

Pathologic Processes
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010