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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00724581

Acronym

PASCART

Enrollment

275

Registered

2008-07-29

Start date

2008-08-31

Completion date

2009-12-31

Last updated

2008-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, amiodarone

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.

Interventions

DRUGAmiodarone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Free of atrial fibrillation	31082009

Secondary

Measure	Time frame
Cost-benefit analysis of amiodarone prophylactic	31082009

Countries

Denmark

Contacts

Primary ContactLars R Zebis, MD

lrz@post.tele.dk+45 89495566

Backup ContactThomas Decker, MD

+45 89495566

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026