Atrial Fibrillation
Conditions
Keywords
amiodarone, atrial fibrillation, surgical procedures, thoracic
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.
Interventions
DRUGAmiodarone
Sponsors
Purdue University
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Atrial Fibrillation Requiring Treatment | 7 days |
| Incidence of Atrial Fibrillation Lasting Longer Than 30 Seconds | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Length of Intensive Care Unit Stay | Duration of hospitalization |
| Length of Hospital Stay | Duration of hospitalization |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Amiodarone Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery | 65 |
| Control Control group | 65 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Lack of GI access to continue | 2 | 0 |
Baseline characteristics
| Characteristic | Control | Amiodarone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 26 Participants | 21 Participants | 47 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 44 Participants | 83 Participants |
| Age Continuous | 63 years STANDARD_DEVIATION 9 | 61 years STANDARD_DEVIATION 8 | 62 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 65 participants | 65 participants | 130 participants |
| Sex: Female, Male Female | 34 Participants | 31 Participants | 65 Participants |
| Sex: Female, Male Male | 31 Participants | 34 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 65 | 22 / 65 |
| serious Total, serious adverse events | 2 / 65 | 1 / 65 |
Outcome results
Primary
Incidence of Atrial Fibrillation Lasting Longer Than 30 Seconds
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amiodarone | Incidence of Atrial Fibrillation Lasting Longer Than 30 Seconds | 9 Participants |
| Control | Incidence of Atrial Fibrillation Lasting Longer Than 30 Seconds | 22 Participants |
p-value: 0.001Chi-squared
Primary
Incidence of Atrial Fibrillation Requiring Treatment
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amiodarone | Incidence of Atrial Fibrillation Requiring Treatment | 9 participants |
| Control | Incidence of Atrial Fibrillation Requiring Treatment | 21 participants |
p-value: 0.02Chi-squared
Secondary
Length of Hospital Stay
Time frame: Duration of hospitalization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Amiodarone | Length of Hospital Stay | 7 Days |
| Control | Length of Hospital Stay | 8 Days |
p-value: 0.79Wilcoxon (Mann-Whitney)
Secondary
Length of Intensive Care Unit Stay
Time frame: Duration of hospitalization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Amiodarone | Length of Intensive Care Unit Stay | 46 Hours |
| Control | Length of Intensive Care Unit Stay | 84 Hours |
p-value: 0.03Wilcoxon (Mann-Whitney)