Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer (PASCART)

July 28, 2008 updated by: Aarhus University Hospital

Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer: A Controlled, Randomized, Double Blinded Trial

Patients undergoing lung resection due to pulmonary cancer can be compromised in their postoperative period due to atrial fibrillation.

A retrospective analysis performed at our institution indicates that 30 % of the population develope atrial fibrillation in the postoperative period.

Amiodarone is known to diminish the occurence of postoperative atrial fibrillation after heart surgery, why this drug is chosen as a prophylactic agent for the mentioned population.

Amiodarone is administrated twice a day for 5 days at a dose of 600 mg oral treatment after an initial loading bolus og 300 mg intravenously.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

275

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, DK-8200
        • Aarhus University Hospital, Skejby

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Resection of the lung due to confirmed diagnosis of cancer pulmones.
  • Elective operation (scheduled operation for at least one day)
  • Ready to be randomized
  • Patient must be at least 18 at time of operation

Exclusion Criteria:

  • Former operation of the lung
  • Former heart surgery
  • Bradycardia below 40 beats/ min
  • Hypotension with systolic blood pressure below 80 mmHg
  • AV-blockage of any degree or sick sinus node
  • QTc interval above 440 ms for men or above 460 ms for women
  • Paroxysmal, persistent or permanent atrial fibrillation or flutter
  • Former atrial fibrillation or flutter for more than a month.
  • Pregnant or positive pregnancy test
  • Breastfeeding
  • ALAT of more than twice the normal over limit
  • Treatment with monoamineoxidase inhibitors (MAOI)
  • Allergy to one or more components in amiodarone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: Amiodarone
intravenous bolus of 300 mg oral treatment og 600 mg twice a day for five days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Free of atrial fibrillation
Time Frame: 31082009
31082009

Secondary Outcome Measures

Outcome Measure
Time Frame
Cost-benefit analysis of amiodarone prophylactic
Time Frame: 31082009
31082009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Investigators

  • Principal Investigator: Lars R Zebis, MD, Ph.D., Aarhus University Hospital Skejby

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Anticipated)

August 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

July 28, 2008

First Posted (Estimate)

July 29, 2008

Study Record Updates

Last Update Posted (Estimate)

July 29, 2008

Last Update Submitted That Met QC Criteria

July 28, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2612-3681

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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