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Prevention of Atrial Fibrillation Following Esophagectomy
This study is currently recruiting participants.
Verified by Purdue University, January 2007
First Received: January 8, 2007   No Changes Posted
Sponsor: Purdue University
Collaborators: Indiana University School of Medicine
Clarian Health Partners
Information provided by: Purdue University
ClinicalTrials.gov Identifier: NCT00420017
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Esophagectomy
Drug: Amiodarone
Phase IV

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: Prevention of Atrial Fibrillation Following Thoracoabdominal Esophagectomy Surgery

Resource links provided by NLM:


Further study details as provided by Purdue University:

Primary Outcome Measures:
  • Incidence of atrial fibrillation

Secondary Outcome Measures:
  • Length of post-surgical hospital stay
  • Length of post-surgical intensive care unit stay
  • Incidence of adverse effects

Estimated Enrollment: 130
Study Start Date: September 2005
Estimated Study Completion Date: December 2008
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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  • QTc interval > 450 ms
  • Receiving class Ia or class III antiarrhythmics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00420017

Contacts
Contact: James E Tisdale, PharmD 37-613-2315 ext 306 jtisdale@iupui.edu

Locations
United States, Indiana
Indiana University Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: James E Tisdale, PharmD            
Sponsors and Collaborators
Purdue University
Indiana University School of Medicine
Clarian Health Partners
Investigators
Principal Investigator: James E Tisdale, PharmD Purdue University
  More Information

No publications provided

Study ID Numbers: 0510-23
Study First Received: January 8, 2007
Last Updated: January 8, 2007
ClinicalTrials.gov Identifier: NCT00420017     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Purdue University:
Amiodarone
Atrial fibrillation
Surgical procedures, thoracic

Additional relevant MeSH terms:
Vasodilator Agents
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Cardiovascular Agents
Amiodarone
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Atrial Fibrillation
Anti-Arrhythmia Agents
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 09, 2010