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Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery

This study has been completed.
Sponsor:
Collaborator:
Purdue University
Information provided by (Responsible Party):
James E. Tisdale, Purdue University
ClinicalTrials.gov Identifier:
NCT00127712
First received: August 4, 2005
Last updated: September 6, 2013
Last verified: September 2013

August 4, 2005
September 6, 2013
September 2004
February 2008   (final data collection date for primary outcome measure)
  • Incidence of Atrial Fibrillation Requiring Treatment [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Incidence of Atrial Fibrillation Lasting Longer Than 30 Seconds [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Determine whether amiodarone can be used to decrease the incidence of atrial fibrillation following non-cardiac thoracic surgery
Complete list of historical versions of study NCT00127712 on ClinicalTrials.gov Archive Site
  • Length of Intensive Care Unit Stay [ Time Frame: Duration of hospitalization ] [ Designated as safety issue: No ]
  • Length of Hospital Stay [ Time Frame: Duration of hospitalization ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery
Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Atrial Fibrillation
Drug: Amiodarone
  • Experimental: Amiodarone
    Amiodarone 1050 mg via continuous intravenous infusion for 24 hours followed by 400 mg orally twice daily for 6 days
    Intervention: Drug: Amiodarone
  • No Intervention: No treatment
    Patients in this group receive no intervention
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
February 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00127712
0407-16
Yes
James E. Tisdale, Purdue University
Indiana University
Purdue University
Principal Investigator: James E Tisdale, PharmD Department of Pharmacy Practice- School of Pharmacy and Pharmacal Sciences- Purdue University
Indiana University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP