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

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Amiodarone
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial fibrillation, amiodarone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University Hospital, Skejby

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

Free of atrial fibrillation

Secondary Outcome Measures

Cost-benefit analysis of amiodarone prophylactic

Full Information

First Posted
July 25, 2008
Last Updated
July 28, 2008
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00724581
Brief Title
Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer
Acronym
PASCART
Official Title
Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer: A Controlled, Randomized, Double Blinded Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, amiodarone

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
275 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Amiodarone
Intervention Description
intravenous bolus of 300 mg oral treatment og 600 mg twice a day for five days
Primary Outcome Measure Information:
Title
Free of atrial fibrillation
Time Frame
31082009
Secondary Outcome Measure Information:
Title
Cost-benefit analysis of amiodarone prophylactic
Time Frame
31082009

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lars R Zebis, MD
Phone
+45 89495566
Email
lrz@post.tele.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Decker, MD
Phone
+45 89495566
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars R Zebis, MD, Ph.D.
Organizational Affiliation
Aarhus University Hospital Skejby
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital, Skejby
City
Aarhus
ZIP/Postal Code
DK-8200
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars R Zebis, MD, Ph.D.
Phone
+45 89495566
Email
lrz@post.tele.dk
First Name & Middle Initial & Last Name & Degree
Thomas D Christensen, MD, Ph.D.
Phone
+45 89495566
First Name & Middle Initial & Last Name & Degree
Lars R Zebis, MD, Ph.D.

12. IPD Sharing Statement

Learn more about this trial

Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer

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