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

NCT00724581 | Unknown Phase 4 DMC

• 1 other identifier: 2612-3681
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, amiodarone

Outcome Measures

Primary Outcomes (1)

• Free of atrial fibrillation

  31082009

Secondary Outcomes (1)

• Cost-benefit analysis of amiodarone prophylactic

  31082009

Study Arms (1)

A

EXPERIMENTAL

Drug: Amiodarone

Interventions

Amiodarone DRUG

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

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University Hospital, Skejby

Aarhus, DK-8200, Denmark

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lars R Zebis, MD, Ph.D.

  Aarhus University Hospital Skejby

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars R Zebis, MD

CONTACT

+45 89495566; lrz@post.tele.dk

Thomas Decker, MD

CONTACT

+45 89495566

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 29, 2008

Record last verified: 2008-07

Locations

DK (1)