NCT00420017

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4 atrial-fibrillation

Timeline
Completed

Started Sep 2005

Typical duration for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

February 6, 2013

Completed
Last Updated

September 18, 2013

Status Verified

September 1, 2013

Enrollment Period

3.2 years

First QC Date

January 8, 2007

Results QC Date

July 27, 2010

Last Update Submit

September 6, 2013

Conditions

Atrial FibrillationEsophagectomy

Keywords

AmiodaroneAtrial fibrillationSurgical procedures, thoracic

Outcome Measures

Primary Outcomes (1)

  • Incidence of Atrial Fibrillation

    7 days

Secondary Outcomes (3)

  • Length of Post-surgical Hospital Stay

    Duration of hospitalization

  • Length of Post-surgical Intensive Care Unit Stay

    7 days

  • Number of Participants With Adverse Effects

    7 days

Study Arms (2)

Amiodarone

EXPERIMENTAL

Intravenous amiodarone

Drug: Amiodarone

Control

OTHER

Control

Other: Control

Interventions

AmiodaroneDRUG

Intravenous amiodarone continuous infusion x 4 days

Amiodarone
ControlOTHER

No amiodarone

Control

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • 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.

    PMID: 20381077RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Limitations and Caveats

Design not double-blind placebo-control Atrial fibrillation was left to discretion of treating MD Larger study necessary to determine differences in length of hospital stay and cost and identify infrequently occurring amiodarone adverse effects

Results Point of Contact

Title
James E Tisdale PharmD
Organization
Purdue University
hwroblew@iupui.edu
317-613-2315

Study Officials

  • James E Tisdale, PharmD

    Purdue University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Interim Head, Department of Pharmacy Practice, Purdue University, and Adjunct Professor, School of Medicine, Indiana University

Study Record Dates

First Submitted

January 8, 2007

First Posted

January 9, 2007

Study Start

September 1, 2005

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

September 18, 2013

Results First Posted

February 6, 2013

Record last verified: 2013-09

Locations

US(1)