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

Phase 3

Terminated

• Conditions: Lung Cancer; Atrial Fibrillation
• Interventions: Other: Control arm, standard care; Drug: Amiodarone

• Registration Number: NCT00300495
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-03-08
• Study First Submitted QC: 2006-03-08
• Study First Posted: 2006-03-09
• Primary Completion: 2009-10-13
• Study Completion: 2009-10-13
• Status Verified: 2017-03
• Results First Submitted: 2017-03-20
• Results First Submitted QC: 2017-03-20
• Last Update Submitted: 2017-03-20
• Results First Posted: 2017-04-28
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 - Control	Control arm, standard care	Control arm, standard care with no perioperative amiodarone
1 - Amiodarone	Amiodarone	Perioperative amiodarone

Primary Outcome Measures

Name	Time	Method
Incidence of Post-operative Atrial Fibrillation	30 days	Number of patients with post-operative atrial fibrillation

Secondary Outcome Measures

Name	Time	Method
Length of Post-operative Hospital Stay	1 week on average	Length of hospital stay after the operation

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States