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

Phase 4

• Conditions: Atrial Fibrillation
• Interventions: Drug: Amiodarone

• Registration Number: NCT00724581
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-07
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-28
• Last Update Submitted: 2008-07-28
• Study First Posted: 2008-07-29
• Last Update Posted: 2008-07-29
• Study Start: 2008-08
• Primary Completion: 2009-08
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 275

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Amiodarone	-

Primary Outcome Measures

Name	Time	Method
Free of atrial fibrillation	31082009

Secondary Outcome Measures

Name	Time	Method
Cost-benefit analysis of amiodarone prophylactic	31082009

Trial Locations

Locations (1)

Aarhus University Hospital, Skejby; 🇩🇰 Aarhus, Denmark