Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127712
Status:
COMPLETED
Last Update Posted:
2013-09-18
First Post:
2005-08-04
Brief Title:
Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None