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Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer (PASCART)

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ClinicalTrials.gov Identifier: NCT00724581
Recruitment Status : Unknown
Verified July 2008 by Aarhus University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 29, 2008
Last Update Posted : July 29, 2008
Information provided by:
Aarhus University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Amiodarone Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 275 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer: A Controlled, Randomized, Double Blinded Trial
Study Start Date : August 2008
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Drug: Amiodarone
intravenous bolus of 300 mg oral treatment og 600 mg twice a day for five days

Primary Outcome Measures :
  1. Free of atrial fibrillation [ Time Frame: 31082009 ]

Secondary Outcome Measures :
  1. Cost-benefit analysis of amiodarone prophylactic [ Time Frame: 31082009 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00724581

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

Aarhus University Hospital, Skejby Not yet recruiting
Aarhus, Denmark, DK-8200
Contact: Lars R Zebis, MD, Ph.D.    +45 89495566    lrz@post.tele.dk   
Contact: Thomas D Christensen, MD, Ph.D.    +45 89495566      
Principal Investigator: Lars R Zebis, MD, Ph.D.         
Sponsors and Collaborators
Aarhus University Hospital
Principal Investigator: Lars R Zebis, MD, Ph.D. Aarhus University Hospital Skejby

Responsible Party: Lars Riber Zebis, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00724581     History of Changes
Other Study ID Numbers: 2612-3681
First Posted: July 29, 2008    Key Record Dates
Last Update Posted: July 29, 2008
Last Verified: July 2008

Keywords provided by Aarhus University Hospital:
Atrial fibrillation, amiodarone

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors