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
Sponsored by
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
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
No
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
No
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
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
No
Learn more about this trial
Study of Amiodarone Given Before Lung Surgery to Prevent Atrial Fibrillation After Lung Resection
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