A Prospective, Randomized Controlled Trial Evaluating the Efficacy of Amiodarone in the Prevention of Postoperative Atrial Fibrillation in Patients Undergoing Minimally Invasive Esophagectomy
OHSU Knight Cancer Institute
Summary
This phase II trial studies how well amiodarone works in the prevention of atrial fibrillation (AF) after a minimally invasive esophagectomy (MIE) in patients with esophageal cancer. Atrial fibrillation (AF) is an irregular heart rhythm, usually associated with a rapid rate, that is caused by abnormal electrical activity within the atria. AF is the most common complication after MIE for esophageal cancer. There has never been a study of AF after MIE that has used unbiased assignment of patients to receive preventative amiodarone or not. Further, there is no standard recommendation or guideline for preventative medications, such as amiodarone, to decrease the risk of AF in patients having MIE performed for cancer. In fact, most medical centers in the United States and around the world do not give preventative amiodarone after esophagectomy. Giving amiodarone after MIE surgery may be able to reduce the risk of AF for patients with esophageal cancer.
Description
PRIMARY OBJECTIVE: I. To evaluate the effect of prophylactic amiodarone on the rate of atrial fibrillation (AF) in patients undergoing minimally invasive esophagectomy (MIE). SECONDARY OBJECTIVES: I. In each subobjective, below, evaluations of the effects of prophylactic amiodarone on the following will be made: * Ia. Postoperative (PostOp) rapid ventricular response; * Ib. Postop pulmonary complications; * Ic. Postop anastomotic leak; * Id. Intensive care unit (ICU) readmission; * Ie. ICU length of stay (LOS); * If. Hospital LOS; * Ig. 30-day readmission; * Ih. Inpatient mortality; * Ii.…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * All patients undergoing MIE will be evaluated for potential enrollment * Indication of cancer, esophageal dysplasia or esophageal dysmotilities * Age \> 18 years * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * History of chronic or paroxysmal AF, or atrial flutter * Previous severe adverse reaction or contraindication to amiodarone (e.g., pulmonary toxicity/fibrosis, hepatotoxicity, thyroid dysfunction) * Current preoperative use of amiodarone, as baseline home medication * Development of AF intraoperativ…
Interventions
- DrugAmiodarone Hydrochloride
Given IV and via feeding tube
- OtherSaline
Given IV
Location
- OHSU Knight Cancer InstitutePortland, Oregon