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

Primary Purpose

Atrial Fibrillation, Lung Cancer

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Amiodarone

Control arm, standard care

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Lung cancer, Pulmonary resection, Post-operative complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1 - Amiodarone

2 - Control

Arm Description

Perioperative amiodarone

Control arm, standard care with no perioperative amiodarone

Outcomes

Primary Outcome Measures

Incidence of Post-operative Atrial Fibrillation

Number of patients with post-operative atrial fibrillation

Secondary Outcome Measures

Length of Post-operative Hospital Stay

Length of hospital stay after the operation

Full Information

NCT ID

NCT00300495

First Posted

March 8, 2006

Last Updated

March 20, 2017

Sponsor

Beth Israel Deaconess Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00300495

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Terminated

Why Stopped

Unable to accrual total number of participants during study period.

Study Start Date

February 2006 (Actual)

Primary Completion Date

October 13, 2009 (Actual)

Study Completion Date

October 13, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Lung Cancer

Keywords

Atrial fibrillation, Lung cancer, Pulmonary resection, Post-operative complications

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 - Amiodarone

Arm Type

Experimental

Arm Description

Perioperative amiodarone

Arm Title

2 - Control

Arm Type

Active Comparator

Arm Description

Control arm, standard care with no perioperative amiodarone

Intervention Type

Drug

Intervention Name(s)

Amiodarone

Other Intervention Name(s)

Cordarone, Pacerone

Intervention Description

Perioperative orally administered

Intervention Type

Other

Intervention Name(s)

Control arm, standard care

Intervention Description

Control

Primary Outcome Measure Information:

Title

Incidence of Post-operative Atrial Fibrillation

Description

Number of patients with post-operative atrial fibrillation

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Length of Post-operative Hospital Stay

Description

Length of hospital stay after the operation

Time Frame

1 week on average

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Malcolm M DeCamp, MD

Organizational Affiliation

Beth Israel Deaconess Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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