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

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase IV

Supportive care

Approved-not yet active

18 and over

Other

2612-3681
NCT00724581

Trial Description

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.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Aarhus Universitetshospital - Aarhus Sygehus

Lars R Zebis, MD, Ph.D.

Principal Investigator

Lars R Zebis, MD		Ph: +45 89495566
		Email: lrz@post.tele.dk

Thomas Decker, MD

Ph: +45 89495566

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00724581
Information obtained from ClinicalTrials.gov on July 29, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.