NCT00127712

Brief Summary

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

  • Determine the effectiveness of amiodarone for the prevention of AF following non-cardiac open-chest surgery;
  • Determine the influence of the prevention of AF following non-cardiac thoracic surgery on post-surgical duration of stay in the Intensive Care Unit (ICU); post-surgical duration of stay in a hospital unit that employs cardiac monitoring; and duration of post-surgical hospital stay; and
  • Determine the safety of amiodarone for the prevention of AF following non-cardiac open-chest surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P25-P50 for phase_4 atrial-fibrillation

Timeline
Completed

Started Sep 2004

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, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

March 24, 2010

Completed
Last Updated

September 18, 2013

Status Verified

September 1, 2013

Enrollment Period

3.4 years

First QC Date

August 4, 2005

Results QC Date

March 2, 2010

Last Update Submit

September 6, 2013

Conditions

Atrial Fibrillation

Keywords

amiodaroneatrial fibrillationsurgical procedures, thoracic

Outcome Measures

Primary Outcomes (2)

  • Incidence of Atrial Fibrillation Requiring Treatment

    7 days

  • Incidence of Atrial Fibrillation Lasting Longer Than 30 Seconds

    7 days

Secondary Outcomes (2)

  • Length of Intensive Care Unit Stay

    Duration of hospitalization

  • Length of Hospital Stay

    Duration of hospitalization

Study Arms (2)

Amiodarone

EXPERIMENTAL

Amiodarone 1050 mg via continuous intravenous infusion for 24 hours followed by 400 mg orally twice daily for 6 days

Drug: Amiodarone

No treatment

NO INTERVENTION

Patients in this group receive no intervention

Interventions

AmiodaroneDRUG
Amiodarone

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 pneumonectomy or lobectomy

You may not qualify if:

  • History (hx) of atrial fibrillation
  • Prior severe side effects from amiodarone
  • Elevated liver enzymes \>3 times the upper limit of normal (UNL)
  • QTc interval \> 450 ms
  • Receiving class Ia or class III antiarrhythmics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University

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 trial evaluating amiodarone for prevention of atrial fibrillation after pulmonary resection. Ann Thorac Surg. 2009 Sep;88(3):886-93; discussion 894-5. doi: 10.1016/j.athoracsur.2009.04.074.

    PMID: 19699916RESULT

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

Results Point of Contact

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

Study Officials

  • James E Tisdale, PharmD

    Department of Pharmacy Practice- School of Pharmacy and Pharmacal Sciences- 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, Dept of Pharmacy Practice, Purdue University and Adjunct Professor, School of Medicine, Indiana University

Study Record Dates

First Submitted

August 4, 2005

First Posted

August 8, 2005

Study Start

September 1, 2004

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

September 18, 2013

Results First Posted

March 24, 2010

Record last verified: 2013-09

Locations

US(1)