Clinical trial NCT00127712: Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery
Official title: Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: amiodarone
atrial fibrillation
surgical procedures, thoracic
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Purdue University
First posted: 2005-08-08
Enrollment: 130
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Incidence of Atrial Fibrillation Requiring Treatment
timeFrame: 7 days
measure: Incidence of Atrial Fibrillation Lasting Longer Than 30 Seconds
timeFrame: 7 days
Secondary outcomes:
measure: Length of Intensive Care Unit Stay
timeFrame: Duration of hospitalization
measure: Length of Hospital Stay
timeFrame: Duration of hospitalization
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Department of Pharmacy Practice- School of Pharmacy and Pharmacal Sciences- Purdue University
name: James E Tisdale, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tisdale JE, Wroblewski HA, Wall DS, Rieger KM, Hammoud ZT, Young JV, Kesler KA. A randomized trial evaluating amiodarone for prevention of atrial fibrillation after pulmonary resection. Ann Thorac Surg. 2009 Sep;88(3):886-93; discussion 894-5. doi: 10.1016/j.athoracsur.2009.04.074.