Official Title: “Prevention of Atrial Fibrillation Following Thoracoabdominal Esophagectomy Surgery”

The investigators hypothesize that the medication amiodarone decreases the incidence of atrial fibrillation (AF) following esophagectomy surgery. Their specific aims are to:

Determine the effectiveness of amiodarone for the prevention of AF following esophagectomy surgery; Determine the influence of the prevention of AF following esophagectomy surgery on post-surgical duration of stay in the Intensive Care Unit ICU)and duration of post-surgical hospital stay; and Determine the safety of amiodarone for the prevention of AF following esophagectomy surgery.

Study Type: Interventional

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

Thousands of patients undergo major esophagectomy surgery in the United States each year, during which all or a portion of the esophagus is removed. A major complication of these 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 esophagectomy 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 esophagectomy is significantly higher in patients who develop AF compared with those who do not. Therefore, the occurrence of this irregular heartbeat following esophagectomy 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 esophagectomy has not been well studied, and amiodarone has not been studied in a controlled trial for the prevention of AF in this population. 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

Primary Measures

• Incidence of atrial fibrillation

Secondary Measures

• Length of post-surgical hospital stay
• Length of post-surgical intensive care unit stay
• Incidence of adverse effects

Inclusion Criteria:

• Males or females over the age of 40
• Scheduled to undergo esophagectomy

Exclusion Criteria:

• History 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 Purdue University  

Overall Contact: James E Tisdale, PharmD 37-613-2315 jtisdale@iupui.edu

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00420017

Study ID Number: 0510-23

ClinicalTrials.gov Identifier: NCT00420017

Health Authority: United States: Institutional Review Board