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

Aarhus University Hospital

Status and phase: Unknown; Phase 4

Conditions: Atrial Fibrillation

Treatments: Drug: Amiodarone

Study type: Interventional

Funder types: Other

Identifiers

NCT00724581

2612-3681

Details and patient eligibility

About

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.

Enrollment: 275 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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275 participants in 1 patient group

A

Experimental group

Treatment:

Drug: Amiodarone