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Prevention of Atrial Fibrillation Following Esophagectomy

NCT ID: NCT00420017

Last Updated: 2013-09-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-11-30

Brief Summary

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The investigators hypothesize that the medication amiodarone decreases the incidence of atrial fibrillation (AF) following esophagectomy surgery. Their specific aims are to:

Determine the effectiveness of amiodarone for the prevention of AF following esophagectomy surgery; Determine the influence of the prevention of AF following esophagectomy surgery on post-surgical duration of stay in the Intensive Care Unit ICU)and duration of post-surgical hospital stay; and Determine the safety of amiodarone for the prevention of AF following esophagectomy surgery.

Detailed Description

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Thousands of patients undergo major esophagectomy surgery in the United States each year, during which all or a portion of the esophagus is removed. A major complication of these surgeries is the occurrence of an irregular heartbeat known as atrial fibrillation (AF), which develops in up to 40% of patients undergoing these procedures. AF is characterized by rapid, irregular, chaotic beating of the two smaller chambers of the heart (the atria), leading to rapid, irregular beating of the two larger chambers (the ventricles). The average time to occurrence of post-surgical AF is 2-3 days following surgery. AF occurring following esophagectomy can result in extremely rapid heart rates, as fast as 150-200 beats per minute, and may be associated with serious consequences, including severely low blood pressure and potentially debilitating stroke. Further, the risk of death following esophagectomy is significantly higher in patients who develop AF compared with those who do not. Therefore, the occurrence of this irregular heartbeat following esophagectomy is associated with severe, potentially life-threatening consequences. Prevention of this irregular heartbeat in these patients may therefore be very important.

Amiodarone is a medication that is known to be effective for prevention and treatment of AF that occurs in patients who have not undergone surgery. In addition, amiodarone has been shown to be effective for prevention of AF following open-chest heart surgery. However, the use of medications for prevention of AF following esophagectomy has not been well studied, and amiodarone has not been studied in a controlled trial for the prevention of AF in this population. In addition, amiodarone is associated with side effects, and it is important to determine the safety of this medication when used in this patient population.

Conditions

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Atrial Fibrillation Esophagectomy

Keywords

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Amiodarone Atrial fibrillation Surgical procedures, thoracic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Amiodarone

Intravenous amiodarone

Group Type EXPERIMENTAL

Amiodarone

Intervention Type DRUG

Intravenous amiodarone continuous infusion x 4 days

Control

Control

Group Type OTHER

Control

Intervention Type OTHER

No amiodarone

Interventions

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Amiodarone

Intravenous amiodarone continuous infusion x 4 days

Intervention Type DRUG

Control

No amiodarone

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Males or females over the age of 40
* Scheduled to undergo esophagectomy

Exclusion Criteria

* History of atrial fibrillation
* Prior severe side effects from amiodarone
* Elevated liver enzymes \>3 times the upper limit of normal (UNL)
* Corrected QT interval \> 450 ms
* Receiving class Ia or class III antiarrhythmics
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Purdue University

OTHER

Sponsor Role collaborator

Indiana University Health

OTHER

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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James E. Tisdale

Professor and Interim Head, Department of Pharmacy Practice, Purdue University, and Adjunct Professor, School of Medicine, Indiana University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James E Tisdale, PharmD

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

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Indiana University Hospital

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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Tisdale JE, Wroblewski HA, Wall DS, Rieger KM, Hammoud ZT, Young JV, Kesler KA. A randomized, controlled study of amiodarone for prevention of atrial fibrillation after transthoracic esophagectomy. J Thorac Cardiovasc Surg. 2010 Jul;140(1):45-51. doi: 10.1016/j.jtcvs.2010.01.026. Epub 2010 Apr 9.

Reference Type RESULT
PMID: 20381077 (View on PubMed)

Other Identifiers

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0510-23

Identifier Type: -

Identifier Source: org_study_id