Prevention of Atrial Fibrillation Following Esophagectomy

This study has been completed.
Sponsor:
Collaborators:
Purdue University
Clarian Health Partners
Information provided by (Responsible Party):
James E. Tisdale, Purdue University
ClinicalTrials.gov Identifier:
NCT00420017
First received: January 8, 2007
Last updated: September 6, 2013
Last verified: September 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Indiana University:

Primary Outcome Measures:
  • Incidence of Atrial Fibrillation [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of Post-surgical Hospital Stay [ Time Frame: Duration of hospitalization ] [ Designated as safety issue: No ]
  • Length of Post-surgical Intensive Care Unit Stay [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Number of Participants With Adverse Effects [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    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

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)
  • Corrected QT interval > 450 ms
  • Receiving class Ia or class III antiarrhythmics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420017

Locations
United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Purdue University
Clarian Health Partners
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
Study First Received: January 8, 2007
Results First Received: July 27, 2010
Last Updated: September 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana 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
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on July 26, 2014