Drug AbsorptionMinimetoNCT01728272
Influence of CPB and Mini CPB to the Absorption of the Metoprolol
A study testing blood concentration of metoprolol in people with Drug Absorption, run by Kuopio University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Absorption
- What is being tested?
- blood concentration of metoprolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Kuopio University Hospital
Kuopio, Kuopio, 70100
Martin Maaroos, MD, 358400218801, martin.maaroos@kuh.fi
Martin Maaroos, MD
About this study
Official title: Influence of CPB and Mini CPB to the Absorption of the Metoprolol After CABG
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.
Read the detailed description
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.
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
- Conditions
- Drug Absorption
- Being tested
- blood concentration of metoprolol
- Keywords
- metoprolol, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood concentration of metoprololDrug
measure blood concentration of metoprolol
| Study group | Role | What they receive |
|---|---|---|
| blood concentration of metoprolol | Experimental | how does off-pump miniperfusion and perfusion CABG influence the absorption of metoprolol after CABG Receives: Drug: blood concentration of metoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
absorbtion of the metoprolol
absorbtion of the metoprolol, blood samples are taken centrifuged, frozed and analyzed
Measured: one year
Secondary outcomes (1)
atrial fibrillation
is there correlation of incidence of the postopeative AF and absorbtion of the metoprolol
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AbsorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728272
- Sponsor's protocol ID
- KUH5101066
- Acronym
- Minimeto
- Status last verified
- Aug 2015
- First submitted
- 13 Nov 2012
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of CPB and Mini CPB to the Absorption of the Metoprolol After CABG
- ClinicalTrials.gov ID
- NCT01728272
- Acronym / sponsor ID
- Minimeto / KUH5101066
- Conditions
- Drug Absorption
- Keywords
- metoprolol, atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 19 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood concentration of metoprolol | Experimental | Drug: blood concentration of metoprololhow does off-pump miniperfusion and perfusion CABG influence the absorption of metoprolol after CABG |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood concentration of metoprololmeasure blood concentration of metoprolol | Drug | blood concentration of metoprolol |
Primary outcome
absorbtion of the metoprolol
Time frame: one year
absorbtion of the metoprolol, blood samples are taken centrifuged, frozed and analyzed
1 secondary outcome
atrial fibrillation
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood concentration of metoprolol in people with Drug Absorption, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
absorbtion of the metoprolol (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015.