Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer

Официальное название

A Prospective, Randomized Controlled Trial Evaluating the Efficacy of Amiodarone in the Prevention of Postoperative Atrial Fibrillation in Patients Undergoing Minimally Invasive Esophagectomy

Обзор

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.

Подробное описание

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;

Il. Evaluating the association between therapeutic (or serum levels and the development of AF in the experimental group only.

EXPLORATORY OBJECTIVE:

I. To evaluate the effect of prophylactic amiodarone administration on hospital cost of care.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive amiodarone hydrochloride intravenously (IV) for 4 days and then via a feeding tube for 3 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo (normal saline) IV for 4 days in the absence of disease progression or unacceptable toxicity.

Patients are followed for 60 days following discharge from hospitalization after MIE.

Вмешательства

• Препарат Amiodarone Hydrochloride
  Given IV and via feeding tube
• Другое Saline
  Given IV

Первичные конечные точки

• Development of atrial fibrillation (AF), or completion of seven-day course of amiodarone [Срок оценки: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 7, after last dose of enteral amiodarone]

Вторичные конечные точки (12)

• Postoperative (PostOp) rapid ventricular response [Срок оценки: From initiation of amiodarone in the intensive care unit (ICU) to discharge (DC) from hospital.]
• Postop pulmonary complications [Срок оценки: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30]
• Anastomotic leak [Срок оценки: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30]
• ICU Readmission [Срок оценки: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30]
• ICU length of stay (LOS) [Срок оценки: From initiation of amiodarone in the intensive care unit (ICU) to time patient is moved out of ICU]
• Hospital LOS [Срок оценки: From initiation of amiodarone in the intensive care unit (ICU) to time of discharge from hospital]
• 30 Day readmission rate [Срок оценки: Day of discharge (DC) from hospital to 30 days after discharge]
• Inpatient morality [Срок оценки: From initiation of amiodarone in the intensive care unit (ICU) to time of discharge from hospital]
• Incidence of mortality within 30 days of surgery [Срок оценки: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30]
• Incidence and type of adverse events [Срок оценки: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30]
• Time to AF [Срок оценки: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 7]
• Serum amiodarone level, classified as therapeutic or subtherapeutic [Срок оценки: Post-operative day (POD) 2 to post-operative day (POD) 3]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• OHSU Knight Cancer Institute — Portland

Идентификаторы

NCT: NCT06067438 · STUDY00021572 · NCI-2023-03642 · STUDY00021572

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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