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

NCT ID: NCT00300495

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2009-10-13

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.

Conditions

Atrial Fibrillation; Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1 - Amiodarone

Perioperative amiodarone

Group Type: EXPERIMENTAL

Amiodarone

Intervention Type: DRUG

Perioperative orally administered

2 - Control

Control arm, standard care with no perioperative amiodarone

Group Type: ACTIVE_COMPARATOR

Control arm, standard care

Intervention Type: OTHER

Control

Interventions

Amiodarone

Perioperative orally administered

Intervention Type: DRUG

Control arm, standard care

Control

Intervention Type: OTHER

Other Intervention Names

Cordarone; Pacerone

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Malcolm DeCamp

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Malcolm M DeCamp, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2005P000376

Identifier Type: -

Identifier Source: org_study_id