Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer

Atrial Fibrillation Clinical Trial

— PASCART  

Official title:

Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer: A Controlled, Randomized, Double Blinded Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00724581
• Other study ID #: 2612-3681
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 25, 2008
• Last updated: July 28, 2008
• Start date: August 2008
• Est. completion date: December 2009

Study information

• Verified date: July 2008
• Source: Aarhus University Hospital
• Contact: Lars R Zebis, MD
• Phone: +45 89495566
• Email: lrz[@]post.tele.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 275
• Est. completion date: December 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Amiodarone
intravenous bolus of 300 mg oral treatment og 600 mg twice a day for five days

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Skejby	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Free of atrial fibrillation		31082009	Yes
Secondary	Cost-benefit analysis of amiodarone prophylactic		31082009	No