A Prospective, Randomized Controlled Trial Evaluating the Efficacy of Amiodarone in the Prevention of Postoperative Atrial Fibrillation in Patients Undergoing Minimally Invasive Esophagectomy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Development of atrial fibrillation (AF), or completion of seven-day course of amiodarone
研究概览
简要总结
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.
详细描述
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. 30-day mortality;
- Ij. Adverse events;
- Ik. Time to AF;
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 intraoperatively
- •Pregnancy
- •Negative pregnancy tests are required for participants of childbearing potential (PCBP) on Day of Surgery (DOS)
- •Breastfeeding/chest feeding
- •Aborted MIE operation
- •QTcF (Fridericia formula) > 500 for heart rate (HR) 60-100 within 30 days
- •For patients with a heart rate (HR) of between 50-59 on their pre-operative screening electrocardiography (EKG), we will first review evidence of chronotropic cardiac response to exercise before inclusion in the study. If a patient's HR increases to ≥ 100 with exercise, the patient is eligible for inclusion of study. Exercise testing options may include a stair climb, a brisk walk, or supine leg-lifts prior to surgery. If exercise is not an option, we can review results of formal stress testing chronotropic response (ie. HR ≥ 100). HR monitoring can be collected by either pulse oximeter or EKG
研究组 & 干预措施
Arm II (normal saline)
Patients receive normal saline IV for 4 days on study.
干预措施: Saline (Other)
Arm I (amiodarone hydrochloride)
Patients receive amiodarone hydrochloride IV for 4 days and then via a feeding tube for 3 days on study.
干预措施: Amiodarone Hydrochloride (Drug)
结局指标
主要结局
Development of atrial fibrillation (AF), or completion of seven-day course of amiodarone
时间窗: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 7, after last dose of enteral amiodarone
Will be a binary variable (yes/no) and analyzed using a one-sided test of two proportions at an alpha level of 0.05.
次要结局
- Incidence of mortality within 30 days of surgery(From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30)
- Time to AF(From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 7)
- Postop pulmonary complications(From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30)
- Anastomotic leak(From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30)
- ICU Readmission(From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30)
- ICU length of stay (LOS)(From initiation of amiodarone in the intensive care unit (ICU) to time patient is moved out of ICU)
- Inpatient morality(From initiation of amiodarone in the intensive care unit (ICU) to time of discharge from hospital)
- Postoperative (PostOp) rapid ventricular response(From initiation of amiodarone in the intensive care unit (ICU) to discharge (DC) from hospital.)
- Hospital LOS(From initiation of amiodarone in the intensive care unit (ICU) to time of discharge from hospital)
- 30 Day readmission rate(Day of discharge (DC) from hospital to 30 days after discharge)
- Incidence and type of adverse events(From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30)
- Serum amiodarone level, classified as therapeutic or subtherapeutic(Post-operative day (POD) 2 to post-operative day (POD) 3)
研究者
Stephanie Wood
Principal Investigator
OHSU Knight Cancer Institute