Study of Amiodarone Given Before Lung Surgery to Prevent Atrial Fibrillation After Lung Resection

Beth Israel Lahey Health

Status and phase: Terminated; Phase 3

Conditions: Atrial Fibrillation; Lung Cancer

Treatments: Drug: Amiodarone; Other: Control arm, standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT00300495

2005P000376

Details and patient eligibility

About

Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation. We propose a randomized controlled trial to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.

Full description

Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation.

We propose a study to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Resectable lung nodule or mass

Exclusion criteria

• Allergy to amiodarone
• Currently taking amiodarone
• Documented atrial fibrillation within past 12 months
• Known pulmonary fibrosis
• Known hepatic dysfunction
• Thyroid disease
• 2nd or 3rd degree heart block
• Severe SA node disease
• Bradycardia-induced syncope
• Pregnancy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

1 - Amiodarone

Experimental group

Description:

Perioperative amiodarone

Treatment:

Drug: Amiodarone

2 - Control

Active Comparator group

Description:

Control arm, standard care with no perioperative amiodarone

Treatment:

Other: Control arm, standard care