Atrial Fibrillation, Lung Cancer
Conditions
Keywords
Atrial fibrillation, Lung cancer, Pulmonary resection, Post-operative complications
Brief summary
Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation. We propose a randomized controlled trial to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.
Detailed description
Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation. We propose a study to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.
Interventions
DRUGAmiodarone
Perioperative orally administered
OTHERControl arm, standard care
Control
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Resectable lung nodule or mass
Exclusion criteria
* Allergy to amiodarone * Currently taking amiodarone * Documented atrial fibrillation within past 12 months * Known pulmonary fibrosis * Known hepatic dysfunction * Thyroid disease * 2nd or 3rd degree heart block * Severe SA node disease * Bradycardia-induced syncope * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Post-operative Atrial Fibrillation | 30 days | Number of patients with post-operative atrial fibrillation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Post-operative Hospital Stay | 1 week on average | Length of hospital stay after the operation |
Countries
United States
Participant flow
Pre-assignment details
One patient in the control group was excluded because, after patient was enrolled, patient had mediastinoscopy that showed more advanced disease. Thus, patient did not undergo lung resection. Therefore this patient was excluded from the study.
Participants by arm
| Arm | Count |
|---|---|
| 1 - Amiodarone Perioperative amiodarone
Amiodarone: Perioperative orally administered | 10 |
| 2 - Control Control arm, standard care with no perioperative amiodarone
Control arm, standard care: Control | 9 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 4 | 1 |
Baseline characteristics
| Characteristic | 2 - Control | Total | 1 - Amiodarone |
|---|---|---|---|
| Age, Customized Age > 18 | 9 Participants | 19 Participants | 10 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 9 participants | 19 participants | 10 participants |
| Sex/Gender, Customized Male | 4 Participants | 10 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 8 |
| other Total, other adverse events | 0 / 6 | 0 / 8 |
| serious Total, serious adverse events | 0 / 6 | 0 / 8 |
Outcome results
Primary
Incidence of Post-operative Atrial Fibrillation
Number of patients with post-operative atrial fibrillation
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1 - Amiodarone | Incidence of Post-operative Atrial Fibrillation | 1 Participants |
| 2 - Control | Incidence of Post-operative Atrial Fibrillation | 1 Participants |
Secondary
Length of Post-operative Hospital Stay
Length of hospital stay after the operation
Time frame: 1 week on average
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 - Amiodarone | Length of Post-operative Hospital Stay | 5 Days | Standard Deviation 2 |
| 2 - Control | Length of Post-operative Hospital Stay | 5 Days | Standard Deviation 4 |