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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Aarhus University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT00724581
First received: July 25, 2008
Last updated: July 28, 2008
Last verified: July 2008
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

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
Experimental: A 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 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
Investigators
Principal Investigator: Lars R Zebis, MD, Ph.D. Aarhus University Hospital
  More Information

No publications provided

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

Keywords provided by Aarhus University Hospital:
Atrial fibrillation, amiodarone

Additional relevant MeSH terms:
Atrial Fibrillation
Lung Neoplasms
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Amiodarone
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on June 13, 2013