Amiodarone Prophylaxis for Atrial Fibrillation in Patient... | NCT00724581

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

NCT00724581

Sponsor

Aarhus University Hospital

Status

Unknown status

Last Update Posted

Jul 29, 2008Estimated

Enrollment

275Estimated

Phase

Phase 4

Conditions

Atrial Fibrillation

Interventions

Amiodarone

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Aug 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Jul 25, 2008

First Submission Date that Met QC Criteria

Jul 28, 2008

First Posted Date

Jul 29, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2008

Last Update Posted Date

Jul 29, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

275Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Drug: Amiodarone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amiodarone	Drug	intravenous bolus of 300 mg oral treatment og 600 mg twice a day for five days	A

Measure	Description	Time Frame
Free of atrial fibrillation		31082009

Measure	Description	Time Frame
Cost-benefit analysis of amiodarone prophylactic		31082009

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lars R Zebis, MD	Contact	+45 89495566		lrz@post.tele.dk
Thomas Decker, MD	Contact	+45 89495566

Overall Officials

Name	Affiliation	Role
Lars R Zebis, MD, Ph.D.	Aarhus University Hospital Skejby	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital, Skejby		Aarhus		DK-8200	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000638	Amiodarone

Ancestor Terms

ID	Term
D001572	Benzofurans
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided