Prevention of Atrial Fibrillation Following Esophagectomy

Atrial Fibrillation Clinical Trial

Official title:

Prevention of Atrial Fibrillation Following Thoracoabdominal Esophagectomy Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420017
• Other study ID #: 0510-23
• Status: Completed
• Phase: Phase 4
• First received: January 8, 2007
• Last updated: September 6, 2013
• Start date: September 2005
• Est. completion date: November 2008

Study information

• Verified date: September 2013
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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)

• Corrected QT interval > 450 ms

• Receiving class Ia or class III antiarrhythmics

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Esophagectomy

Intervention

Drug:
• Amiodarone
Intravenous amiodarone continuous infusion x 4 days

Other:
• Control
No amiodarone

Locations

Country	Name	City	State
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	Indiana University Health, Purdue University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tisdale JE, Wroblewski HA, Wall DS, Rieger KM, Hammoud ZT, Young JV, Kesler KA. A randomized, controlled study of amiodarone for prevention of atrial fibrillation after transthoracic esophagectomy. J Thorac Cardiovasc Surg. 2010 Jul;140(1):45-51. doi: 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Atrial Fibrillation		7 days	No
Secondary	Length of Post-surgical Hospital Stay		Duration of hospitalization	No
Secondary	Length of Post-surgical Intensive Care Unit Stay		7 days	No
Secondary	Number of Participants With Adverse Effects	Adverse effects, including cardiovascular (hypotension, bradycardia, prolonged QT interval, ventricular tachycardia), respiratory (ARDS, pneumonia, atelectasis), and other (pericardial effusions, anastomotic leak)	7 days	Yes