Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery
Information source: Indiana University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation
Intervention: Amiodarone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Indiana University Official(s) and/or principal investigator(s): James E Tisdale, PharmD, Principal Investigator, Affiliation: Department of Pharmacy Practice- School of Pharmacy and Pharmacal Sciences- Purdue University
Summary
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.
Clinical Details
Official title: Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Incidence of Atrial Fibrillation Requiring TreatmentIncidence of Atrial Fibrillation Lasting Longer Than 30 Seconds
Secondary outcome: Length of Intensive Care Unit StayLength of Hospital Stay
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
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Indiana University, Indianapolis, Indiana 46202, United States
Additional Information
Starting date: September 2004
Last updated: September 6, 2013
|