Prevention of Atrial Fibrillation Following Esophagectomy

September 6, 2013 updated by: James E. Tisdale, Indiana University

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 Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amiodarone
Intravenous amiodarone
Intravenous amiodarone continuous infusion x 4 days
Other: Control
No amiodarone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Atrial Fibrillation
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Post-surgical Hospital Stay
Time Frame: Duration of hospitalization
Duration of hospitalization
Length of Post-surgical Intensive Care Unit Stay
Time Frame: 7 days
7 days
Number of Participants With Adverse Effects
Time Frame: 7 days
Adverse effects, including cardiovascular (hypotension, bradycardia, prolonged QT interval, ventricular tachycardia), respiratory (ARDS, pneumonia, atelectasis), and other (pericardial effusions, anastomotic leak)
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

January 8, 2007

First Submitted That Met QC Criteria

January 8, 2007

First Posted (Estimate)

January 9, 2007

Study Record Updates

Last Update Posted (Estimate)

September 18, 2013

Last Update Submitted That Met QC Criteria

September 6, 2013

Last Verified

September 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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