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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00420017
Other study ID # 0510-23
Secondary ID
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


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
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