Lung InjuryNCT01184313
Acute Lung Injury After Aortic Valve Surgery
An observational study of Lung Injury, run by University of Oulu at 1 site in Finland.
Trial summary
The purpose of this prospective, randomized clinical trial is to understand and measure lung injuries caused by CPB in aortic valve surgery. Study questions: Is there any correlation between the release of pro-inflammatory biomarkers and lung injury degree? Is there any correlation between oxyhaemodynamic parameters… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Injury
- What is being tested?
- aortic valve surgery with CPB
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2010to not given
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: elective aortic valve surgery patients in Oulu University hospital
Who may be able to join
- elective aortic valve surgery patient
- written consent
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Fausto Biancari, MD, PhD contact
Finland1 site
Oulu University hospital
Oulu, 90029
Fausto Biancari, MD, PhD, fausto.biancari@ppshp.fi
Reija Mikkola, MS
About this study
The purpose of this prospective, randomized clinical trial is to understand and measure lung injuries caused by CPB in aortic valve surgery.
Study questions:
- Is there any correlation between the release of pro-inflammatory biomarkers and lung injury degree?
- Is there any correlation between oxyhaemodynamic parameters and lung injury degree?
- Is there any correlation between oxyhaemodynamic parameters and the release of pro-inflammatory biomarkers?
- Are budesonide, erdostein and acetylcystein effective in the prevention of lung injuries?
- Conditions
- Lung Injury
- Being tested
- aortic valve surgery with CPB
- Keywords
- aortic valve surgery, CPB, lung injury
- Medical subject headings
- Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aortic valve surgery with CPBProcedure or surgery
elective aortic valve surgery with CPB
| Study group | Role | What they receive |
|---|---|---|
| aortic valve surgery | Not described Receives: Procedure: aortic valve surgery with CPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung injury
Measured: within the first 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
- Study startSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung InjuryStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Investigators
- Reija Mikkola, MS, Principal investigator, Oulu University HospitalFausto Biancari, MD, PhD, Study director, Oulu University HospitalJuha Koskenkari, MD, Study chair, Oulu University HospitalVesa Pakanen, MD, Study chair, Oulu University HospitalTatu Juvonen, prof., Study chair, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184313
- Sponsor's protocol ID
- Mikkola2010
- Status last verified
- Aug 2010
- First submitted
- 17 Aug 2010
- Last updated
- 3 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Lung Injury After Aortic Valve Surgery
- ClinicalTrials.gov ID
- NCT01184313
- Acronym / sponsor ID
- Mikkola2010
- Conditions
- Lung Injury
- Keywords
- aortic valve surgery, CPB, lung injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- Sep 2010
- First posted
- 18 Aug 2010 (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.
The purpose of this prospective, randomized clinical trial is to understand and measure lung injuries caused by CPB in aortic valve surgery.
Study questions:
- Is there any correlation between the release of pro-inflammatory biomarkers and lung injury degree?
- Is there any correlation between oxyhaemodynamic parameters and lung injury degree?
- Is there any correlation between oxyhaemodynamic parameters and the release of pro-inflammatory biomarkers?
- Are budesonide, erdostein and acetylcystein effective in the prevention of lung injuries?
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aortic valve surgery | – | Procedure: aortic valve surgery with CPB |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- elective aortic valve surgery patients in Oulu University hospital
Key inclusion criteria (2 listed)
- elective aortic valve surgery patient
- written consent
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| aortic valve surgery with CPBelective aortic valve surgery with CPB | Procedure or surgery | aortic valve surgery |
Primary outcome
lung injury
Time frame: within the first 3 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2010.
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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.
Fausto Biancari, MD, PhD contact
Reija Mikkola, MS principal investigator
Oulu University Hospital
Fausto Biancari, MD, PhD study director
Oulu University Hospital
Juha Koskenkari, MD study chair
Oulu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Injury, run by University of Oulu 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 2 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 3 Sep 2010. 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?
Contact Fausto Biancari, MD, PhD (fausto.biancari@ppshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lung injury (time frame: within the first 3 days after surgery). 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 3 Sep 2010.