Influence of CPB and Mini CPB to the Absorption of the Me... | NCT01728272

Studies
Influence of CPB and Mini CPB to the Absorption of the Metoprolol

NCT01728272

Sponsor

Kuopio University Hospital

Status

Unknown status

Last Update Posted

Aug 20, 2015Estimated

Enrollment

45Estimated

Phase

Not Applicable

Conditions

Drug Absorption

Interventions

blood concentration of metoprolol

Countries

Finland

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

Aug 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Nov 13, 2012

First Submission Date that Met QC Criteria

Nov 16, 2012

First Posted Date

Nov 19, 2012Estimated

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

Aug 19, 2015

Last Update Posted Date

Aug 20, 2015Estimated

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

Influence of perfusion, miniperfusion and off pump coronary artery bypass grafting to the absorbtion of metoprolol postoperatively, hypothesis in that miniperfusion and off pump surgery does not decrease absorbtion of the metoprolol compared to conventional pefusion.

Detailed Description

Blood samples for concentration of metoprolol are taken preoperaively, 1. and 3. day after operation, before and 10 times after intake of 50 mg metoprolol.

Sudy is randomized into 3 groups: 1. Miniperfusion n.15 2. Perfusion n.15 3. offpump n.15

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
blood concentration of metoprolol	Experimental	how does off-pump miniperfusion and perfusion CABG influence the absorption of metoprolol after CABG	Drug: blood concentration of metoprolol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood concentration of metoprolol	Drug	measure blood concentration of metoprolol	blood concentration of metoprolol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
absorbtion of the metoprolol	absorbtion of the metoprolol, blood samples are taken centrifuged, frozed and analyzed	one year

Secondary Outcomes

Measure	Description	Time Frame
atrial fibrillation	is there correlation of incidence of the postopeative AF and absorbtion of the metoprolol	one year

Other Outcomes

Measure	Description	Time Frame
recovery from rocedure	How does gereral recovery correlate between randomized groups	one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria: elective CABG patient -

Exclusion Criteria: contraindication to metoprolol

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kuopio University Hospital	Recruiting	Kuopio	Kuopio	70100	Finland

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