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

NCT ID: NCT00724581

Last Updated: 2008-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Keywords

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Atrial fibrillation, amiodarone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Group Type EXPERIMENTAL

Amiodarone

Intervention Type DRUG

intravenous bolus of 300 mg oral treatment og 600 mg twice a day for five days

Interventions

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Amiodarone

intravenous bolus of 300 mg oral treatment og 600 mg twice a day for five days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Aarhus University Hospital

Principal Investigators

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Lars R Zebis, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital Skejby

Locations

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Aarhus University Hospital, Skejby

Aarhus, , Denmark

Site Status

Countries

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Denmark

Central Contacts

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Lars R Zebis, MD

Role: CONTACT

Phone: +45 89495566

Email: [email protected]

Thomas Decker, MD

Role: CONTACT

Phone: +45 89495566

Facility Contacts

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Lars R Zebis, MD, Ph.D.

Role: primary

Thomas D Christensen, MD, Ph.D.

Role: backup

Other Identifiers

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2612-3681

Identifier Type: -

Identifier Source: org_study_id