Prevention of Atrial Fibrillation Following Esophagectomy
Primary Purpose
Atrial Fibrillation, Esophagectomy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Amiodarone
Control
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Amiodarone, Atrial fibrillation, Surgical procedures, thoracic
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
Sites / Locations
- Indiana University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Amiodarone
Control
Arm Description
Intravenous amiodarone
Control
Outcomes
Primary Outcome Measures
Incidence of Atrial Fibrillation
Secondary Outcome Measures
Length of Post-surgical Hospital Stay
Length of Post-surgical Intensive Care Unit Stay
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)
Full Information
NCT ID
NCT00420017
First Posted
January 8, 2007
Last Updated
September 6, 2013
Sponsor
Indiana University
Collaborators
Purdue University, Indiana University Health
1. Study Identification
Unique Protocol Identification Number
NCT00420017
Brief Title
Prevention of Atrial Fibrillation Following Esophagectomy
Official Title
Prevention of Atrial Fibrillation Following Thoracoabdominal Esophagectomy Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Purdue University, Indiana University Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Esophagectomy
Keywords
Amiodarone, Atrial fibrillation, Surgical procedures, thoracic
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amiodarone
Arm Type
Experimental
Arm Description
Intravenous amiodarone
Arm Title
Control
Arm Type
Other
Arm Description
Control
Intervention Type
Drug
Intervention Name(s)
Amiodarone
Intervention Description
Intravenous amiodarone continuous infusion x 4 days
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
No amiodarone
Primary Outcome Measure Information:
Title
Incidence of Atrial Fibrillation
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Length of Post-surgical Hospital Stay
Time Frame
Duration of hospitalization
Title
Length of Post-surgical Intensive Care Unit Stay
Time Frame
7 days
Title
Number of Participants With Adverse Effects
Description
Adverse effects, including cardiovascular (hypotension, bradycardia, prolonged QT interval, ventricular tachycardia), respiratory (ARDS, pneumonia, atelectasis), and other (pericardial effusions, anastomotic leak)
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James E Tisdale, PharmD
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20381077
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.
Results Reference
result
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Prevention of Atrial Fibrillation Following Esophagectomy
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