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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase III Study of Preoperative Amiodarone for Prevention of Atrial Fibrillation After Lung Resection

Conditions
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Atrial Fibrillation, Lung Cancer

Intervention / Treatment
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* Drug: Amiodarone
* Other: Control arm, standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 - Amiodarone<br>Perioperative amiodarone | Drug: Amiodarone<br>* Perioperative orally administered<br>* Other names: Pacerone;|
| Active Comparator: 2 - Control<br>Control arm, standard care with no perioperative amiodarone | Other: Control arm, standard care<br>* Control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Post-operative Atrial Fibrillation | Number of patients with post-operative atrial fibrillation | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Post-operative Hospital Stay | Length of hospital stay after the operation | 1 week on average | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Lung cancer, Pulmonary resection, Post-operative complications