Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
PRIMARY OBJECTIVE:
- To evaluate the effect of prophylactic amiodarone on the rate of atrial fibrillation (AF) in patients undergoing minimally invasive esophagectomy (MIE).
SECONDARY OBJECTIVES:
- In each subobjective, below, evaluations of the effects of prophylactic amiodarone on the following will be made:
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Ia. Postoperative (PostOp) rapid ventricular response;
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Ib. Postop pulmonary complications;
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Ic. Postop anastomotic leak;
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Id. Intensive care unit (ICU) readmission;
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Ie. ICU length of stay (LOS);
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If. Hospital LOS;
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Ig. 30-day readmission;
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Ih. Inpatient mortality;
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Ii. 30-day mortality;
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Ij. Adverse events;
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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:
- 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I (amiodarone hydrochloride) Patients receive amiodarone hydrochloride IV for 4 days and then via a feeding tube for 3 days on study. |
Drug: Amiodarone Hydrochloride
Given IV and via feeding tube
Other Names:
|
| Placebo Comparator: Arm II (normal saline) Patients receive normal saline IV for 4 days on study. |
Other: Saline
Given IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Development of atrial fibrillation (AF), or completion of seven-day course of amiodarone [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.
Secondary Outcome Measures
- Postoperative (PostOp) rapid ventricular response [From initiation of amiodarone in the intensive care unit (ICU) to discharge (DC) from hospital.]
Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% confidence interval (CI) of the difference between the two proportions.
- Postop pulmonary complications [From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30]
Including pneumonia, acute respiratory distress syndrome, acute pulmonary edema, and chylothorax. Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.
- Anastomotic leak [From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30]
Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.
- ICU Readmission [From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30]
Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.
- ICU length of stay (LOS) [From initiation of amiodarone in the intensive care unit (ICU) to time patient is moved out of ICU]
Will be assessed in days. Analysis: Wilcoxon rank sum test
- Hospital LOS [From initiation of amiodarone in the intensive care unit (ICU) to time of discharge from hospital]
Will be assessed in days. Analysis: Wilcoxon rank sum test
- 30 Day readmission rate [Day of discharge (DC) from hospital to 30 days after discharge]
Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.
- Inpatient morality [From initiation of amiodarone in the intensive care unit (ICU) to time of discharge from hospital]
Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.
- Incidence of mortality within 30 days of surgery [From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30]
Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.
- Incidence and type of adverse events [From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30]
Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.
- Time to AF [From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 7]
Analysis: Log-rank test.
- Serum amiodarone level, classified as therapeutic or subtherapeutic [Post-operative day (POD) 2 to post-operative day (POD) 3]
Eligibility Criteria
Criteria
Inclusion Criteria:
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All patients undergoing MIE will be evaluated for potential enrollment
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Indication of cancer, esophageal dysplasia or esophageal dysmotilities
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Age > 18 years
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Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
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History of chronic or paroxysmal AF, or atrial flutter
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Previous severe adverse reaction or contraindication to amiodarone (e.g., pulmonary toxicity/fibrosis, hepatotoxicity, thyroid dysfunction)
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Current preoperative use of amiodarone, as baseline home medication
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Development of AF intraoperatively
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Pregnancy
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Negative pregnancy tests are required for participants of childbearing potential (PCBP) on Day of Surgery (DOS)
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Breastfeeding/chest feeding
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Aborted MIE operation
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QTcB (Bazzett formula) > 500 for heart rate (HR) 60-100 within 30 days
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | OHSU Knight Cancer Institute | Portland | Oregon | United States | 97239 |
Sponsors and Collaborators
- OHSU Knight Cancer Institute
Investigators
- Principal Investigator: Stephanie Wood, OHSU Knight Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00021572
- NCI-2023-03642
- STUDY00021572