Official Title: “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.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2008

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.

Intervention(s) in this Clinical Trial

• Drug: amiodarone - for prophylaxis of atrial fibrillation
  • Control - no prophylaxis with amiodarone
• Other: Control
  • Control

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Amiodarone
  • Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
• No Intervention: Control
  • Control group

Primary Measures

• Determine whether amiodarone can be used to decrease the incidence of atrial fibrillation following non-cardiac thoracic surgery
  • Time Frame: 7 days
    Safety Issue?: No

Secondary Measures

• Length of hospital stay
  • Time Frame: 7 days
    Safety Issue?: No
• Length of intensive care unit stay
  • Time Frame: 7 days
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Purdue University

Overall Clinical Trial Officials and Contacts

James E Tisdale, PharmD Principal Investigator Department of Pharmacy Practice- School of Pharmacy and Pharmacal Sciences- Purdue University  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00127712

Study ID Number: 0407-16

ClinicalTrials.gov Identifier: NCT00127712

Health Authority: United States: Institutional Review Board