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Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Amiodarone
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring amiodarone, atrial fibrillation, surgical procedures, thoracic

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Males or females over the age of 40 Scheduled to undergo pneumonectomy or lobectomy Exclusion Criteria: History (hx) of atrial fibrillation Prior severe side effects from amiodarone Elevated liver enzymes >3 times the upper limit of normal (UNL) QTc interval > 450 ms Receiving class Ia or class III antiarrhythmics

Sites / Locations

  • Indiana University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Amiodarone

No treatment

Arm Description

Amiodarone 1050 mg via continuous intravenous infusion for 24 hours followed by 400 mg orally twice daily for 6 days

Patients in this group receive no intervention

Outcomes

Primary Outcome Measures

Incidence of Atrial Fibrillation Requiring Treatment
Incidence of Atrial Fibrillation Lasting Longer Than 30 Seconds

Secondary Outcome Measures

Length of Intensive Care Unit Stay
Length of Hospital Stay

Full Information

First Posted
August 4, 2005
Last Updated
September 6, 2013
Sponsor
Indiana University
Collaborators
Purdue University
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1. Study Identification

Unique Protocol Identification Number
NCT00127712
Brief Title
Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery
Official Title
Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Purdue University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators hypothesize that the medication amiodarone decreases the incidence of atrial fibrillation (AF) following non-cardiac open-chest surgery. Their specific aims are to: Determine the effectiveness of amiodarone for the prevention of AF following non-cardiac open-chest surgery; Determine the influence of the prevention of AF following non-cardiac thoracic surgery on post-surgical duration of stay in the Intensive Care Unit (ICU); post-surgical duration of stay in a hospital unit that employs cardiac monitoring; and duration of post-surgical hospital stay; and Determine the safety of amiodarone for the prevention of AF following non-cardiac open-chest surgery.
Detailed Description
Thousands of patients undergo major non-cardiac open-chest surgery in the United States each year. These surgeries most often consist of lung surgery, in which one lobe of the lung is removed (lobectomy) or the entire lung is removed (pneumonectomy). A major complication of these non-cardiac open-chest surgeries is the occurrence of an irregular heartbeat known as atrial fibrillation (AF), which develops in up to 40% of patients undergoing these procedures. AF is characterized by rapid, irregular, chaotic beating of the two smaller chambers of the heart (the atria), leading to rapid, irregular beating of the two larger chambers (the ventricles). The average time to occurrence of post-surgical AF is 2-3 days following surgery. AF occurring following major non-cardiac open-chest surgery can result in extremely rapid heart rates, as fast as 150-200 beats per minute, and may be associated with serious consequences, including severely low blood pressure and potentially debilitating stroke. Further, the risk of death following non-cardiac open-chest surgery is significantly higher in patients who develop AF compared with those who do not. Therefore, the occurrence of this irregular heartbeat following non-cardiac open-chest surgery is associated with severe, potentially life-threatening consequences. Prevention of this irregular heartbeat in these patients may therefore be very important. Amiodarone is a medication that is known to be effective for prevention and treatment of AF that occurs in patients who have not undergone surgery. In addition, amiodarone has been shown to be effective for prevention of AF following open-chest heart surgery. However, the use of medications for prevention of AF following non-cardiac open-chest surgery has not been well studied, and amiodarone has not been studied in a controlled trial for the prevention of AF in patients undergoing these procedures. In addition, amiodarone is associated with side effects, and it is important to determine the safety of this medication when used in this patient population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
amiodarone, atrial fibrillation, surgical procedures, thoracic

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amiodarone
Arm Type
Experimental
Arm Description
Amiodarone 1050 mg via continuous intravenous infusion for 24 hours followed by 400 mg orally twice daily for 6 days
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
Patients in this group receive no intervention
Intervention Type
Drug
Intervention Name(s)
Amiodarone
Primary Outcome Measure Information:
Title
Incidence of Atrial Fibrillation Requiring Treatment
Time Frame
7 days
Title
Incidence of Atrial Fibrillation Lasting Longer Than 30 Seconds
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Length of Intensive Care Unit Stay
Time Frame
Duration of hospitalization
Title
Length of Hospital Stay
Time Frame
Duration of hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females over the age of 40 Scheduled to undergo pneumonectomy or lobectomy Exclusion Criteria: History (hx) of atrial fibrillation Prior severe side effects from amiodarone Elevated liver enzymes >3 times the upper limit of normal (UNL) QTc interval > 450 ms Receiving class Ia or class III antiarrhythmics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James E Tisdale, PharmD
Organizational Affiliation
Department of Pharmacy Practice- School of Pharmacy and Pharmacal Sciences- Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19699916
Citation
Tisdale JE, Wroblewski HA, Wall DS, Rieger KM, Hammoud ZT, Young JV, Kesler KA. A randomized trial evaluating amiodarone for prevention of atrial fibrillation after pulmonary resection. Ann Thorac Surg. 2009 Sep;88(3):886-93; discussion 894-5. doi: 10.1016/j.athoracsur.2009.04.074.
Results Reference
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Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery

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