Amiodarone for the Prevention of Atrial Fibrillation After Minimally

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. 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 on study. ARM II: Patients receive placebo (normal saline) IV for 4 days on study. Patients are followed for 60 days following discharge from hospitalization after MIE. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06067438
Study type	Interventional
Source	OHSU Knight Cancer Institute
Contact
Status	Recruiting
Phase	Phase 2
Start date	July 25, 2024
Completion date	August 30, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms