Clinical trial NCT00420017: Prevention of Atrial Fibrillation Following Esophagectomy
Official title: Prevention of Atrial Fibrillation Following Thoracoabdominal Esophagectomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Esophagectomy
Keywords: Amiodarone
Atrial fibrillation
Surgical procedures, thoracic
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Purdue University
name: Indiana University Health
First posted: 2007-01-09
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Atrial Fibrillation
timeFrame: 7 days
Secondary outcomes:
measure: Length of Post-surgical Hospital Stay
timeFrame: Duration of hospitalization
measure: Length of Post-surgical Intensive Care Unit Stay
timeFrame: 7 days
measure: Number of Participants With Adverse Effects
timeFrame: 7 days
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Purdue University
name: James E Tisdale, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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: 10.1016/j.jtcvs.2010.01.026. Epub 2010 Apr 9.