Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery
NCT ID: NCT00127712
Last Updated: 2013-09-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
130 participants
INTERVENTIONAL
2004-09-30
2008-02-29
Brief Summary
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* 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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Amiodarone
Amiodarone 1050 mg via continuous intravenous infusion for 24 hours followed by 400 mg orally twice daily for 6 days
Amiodarone
No treatment
Patients in this group receive no intervention
No interventions assigned to this group
Interventions
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Amiodarone
Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo pneumonectomy or lobectomy
Exclusion Criteria
* 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
40 Years
ALL
No
Sponsors
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Purdue University
OTHER
Indiana University
OTHER
Responsible Party
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James E. Tisdale
Professor and Interim Head, Dept of Pharmacy Practice, Purdue University and Adjunct Professor, School of Medicine, Indiana University
Principal Investigators
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James E Tisdale, PharmD
Role: PRINCIPAL_INVESTIGATOR
Department of Pharmacy Practice- School of Pharmacy and Pharmacal Sciences- Purdue University
Locations
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Indiana University
Indianapolis, Indiana, United States
Countries
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References
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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.
Other Identifiers
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0407-16
Identifier Type: -
Identifier Source: org_study_id