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Prevention of Atrial Fibrillation Following Esophagectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00420017
First Posted: January 9, 2007
Last Update Posted: September 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Purdue University
Indiana University Health
Information provided by (Responsible Party):
James E. Tisdale, Purdue University
  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 Other: Control Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Atrial Fibrillation Following Thoracoabdominal Esophagectomy Surgery

Resource links provided by NLM:


Further study details as provided by James E. Tisdale, Purdue University:

Primary Outcome Measures:
  • Incidence of Atrial Fibrillation [ Time Frame: 7 days ]

Secondary Outcome Measures:
  • Length of Post-surgical Hospital Stay [ Time Frame: Duration of hospitalization ]
  • Length of Post-surgical Intensive Care Unit Stay [ Time Frame: 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)


Enrollment: 80
Study Start Date: September 2005
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amiodarone
Intravenous amiodarone
Drug: Amiodarone
Intravenous amiodarone continuous infusion x 4 days
Control
Control
Other: Control
No amiodarone

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

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)
  • Corrected QT interval > 450 ms
  • Receiving class Ia or class III antiarrhythmics
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420017


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

Publications:
Responsible Party: James E. Tisdale, Professor and Interim Head, Department of Pharmacy Practice, Purdue University, and Adjunct Professor, School of Medicine, Indiana University, Purdue University
ClinicalTrials.gov Identifier: NCT00420017     History of Changes
Other Study ID Numbers: 0510-23
First Submitted: January 8, 2007
First Posted: January 9, 2007
Results First Submitted: July 27, 2010
Results First Posted: February 6, 2013
Last Update Posted: September 18, 2013
Last Verified: September 2013

Keywords provided by James E. Tisdale, Purdue University:
Amiodarone
Atrial fibrillation
Surgical procedures, thoracic

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors