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Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery
This study has been completed.
First Received: August 4, 2005   Last Updated: May 21, 2008   History of Changes
Sponsor: Purdue University
Collaborator: Indiana University
Information provided by: Purdue University
ClinicalTrials.gov Identifier: NCT00127712
  Purpose

The investigators hypothesize that the medication amiodarone decreases the incidence of atrial fibrillation (AF) following non-cardiac open-chest surgery. Their specific aims are to:

  • Determine the effectiveness of amiodarone for the prevention of AF following non-cardiac open-chest surgery;
  • Determine the influence of the prevention of AF following non-cardiac thoracic surgery on post-surgical duration of stay in the Intensive Care Unit (ICU); post-surgical duration of stay in a hospital unit that employs cardiac monitoring; and duration of post-surgical hospital stay; and
  • Determine the safety of amiodarone for the prevention of AF following non-cardiac open-chest surgery.

Condition Intervention Phase
Atrial Fibrillation
Drug: amiodarone - for prophylaxis of atrial fibrillation
Other: Control
Phase IV

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery

Resource links provided by NLM:


Further study details as provided by Purdue University:

Primary Outcome Measures:
  • Determine whether amiodarone can be used to decrease the incidence of atrial fibrillation following non-cardiac thoracic surgery [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Length of intensive care unit stay [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: September 2004
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Amiodarone: Experimental
Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
Drug: amiodarone - for prophylaxis of atrial fibrillation
Control - no prophylaxis with amiodarone
Control: No Intervention
Control group
Other: Control
Control

Detailed Description:

Thousands of patients undergo major non-cardiac open-chest surgery in the United States each year. These surgeries most often consist of lung surgery, in which one lobe of the lung is removed (lobectomy) or the entire lung is removed (pneumonectomy).

A major complication of these non-cardiac open-chest 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 major non-cardiac open-chest surgery 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 non-cardiac open-chest surgery is significantly higher in patients who develop AF compared with those who do not. Therefore, the occurrence of this irregular heartbeat following non-cardiac open-chest surgery 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 non-cardiac open-chest surgery has not been well studied, and amiodarone has not been studied in a controlled trial for the prevention of AF in patients undergoing these procedures. 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 pneumonectomy or lobectomy

Exclusion Criteria:

  • History (hx) 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: NCT00127712

Locations
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Purdue University
Indiana University
Investigators
Principal Investigator: James E Tisdale, PharmD Department of Pharmacy Practice- School of Pharmacy and Pharmacal Sciences- Purdue University
  More Information

No publications provided

Responsible Party: Purdue University ( James Tisdale )
Study ID Numbers: 0407-16
Study First Received: August 4, 2005
Last Updated: May 21, 2008
ClinicalTrials.gov Identifier: NCT00127712     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 08, 2010