Acute Lung InjuryNCT01322295
Human Bronchial Microdialysis in Open Aortic Aneurysm Repair
An observational study of Acute Lung Injury, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Elective open aortic aneurysm repair has an overall reported 30 day mortality of 2-6 percent, but in patients more than 65-70 years the mortality is reported to be more than 10 percent. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Lung Injury
- How many people
- 16 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2011to Dec 2011
- 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: Patients assigned for elective open aortic surgery are enrolled by invitation
Who may be able to join
- Patients assigned for elective open aortic surgery
Who cannot join
- Moderate to severe COPD
Trial locations and contacts
1 site in 1 country.
About this study
Elective open aortic aneurysm repair has an overall reported 30 day mortality of 2-6 percent, but in patients more than 65-70 years the mortality is reported to be more than 10 percent. The phenomenon of acute lung injury (ALI)/adult respiratory distress syndrome (ARDS) after infra renal abdominal aneurysm repair caused by ischemia-reperfusion is well established. The degree of disability varies from a light degree of acute respiratory failure to mortality for patients with the same profile of risk.
Primary aim is to develop a model that monitors inflammatory marker molecules collected from the bronchial epithelial lining fluid by microdialysis. The method with examination of the bronchial epithelial lining fluid by microdialysis and analysis of multiple inflammation markers as previously done by the investigators group.
- Conditions
- Acute Lung Injury
- Medical subject headings
- Acute Lung Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokines in bronchial epithelial lining fluid
Measured: Within 4 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Erik Solligård, md phd, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322295
- Sponsor's protocol ID
- 2010/1649a
- Status last verified
- Sep 2017
- First submitted
- 23 Mar 2011
- Last updated
- 21 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tyvold SS, Solligard E, Gunnes S, Lyng O, Johannisson A, Gronbech JE, Aadahl P. Bronchial microdialysis of cytokines in the epithelial lining fluid in experimental intestinal ischemia and reperfusion before onset of manifest lung injury. Shock. 2010 Nov;34(5):517-24. doi: 10.1097/SHK.0b013e3181dfc430.
PubMed 20354465Tyvold SS, Dahl T, Dragsund S, Gunnes S, Lyng O, Damas JK, Aadahl P, Solligard E. Bronchial microdialysis monitoring of inflammatory response in open abdominal aortic aneurysm repair; an observational study. Physiol Rep. 2017 Jul;5(14):e13348. doi: 10.14814/phy2.13348.
PubMed 28743822
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Bronchial Microdialysis in Open Aortic Aneurysm Repair
- ClinicalTrials.gov ID
- NCT01322295
- Acronym / sponsor ID
- 2010/1649a
- Conditions
- Acute Lung Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Mar 2011 (actual)
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Mar 2011 (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.
Elective open aortic aneurysm repair has an overall reported 30 day mortality of 2-6 percent, but in patients more than 65-70 years the mortality is reported to be more than 10 percent. The phenomenon of acute lung injury (ALI)/adult respiratory distress syndrome (ARDS) after infra renal abdominal aneurysm repair caused by ischemia-reperfusion is well established. The degree of disability varies from a light degree of acute respiratory failure to mortality for patients with the same profile of risk.
Primary aim is to develop a model that monitors inflammatory marker molecules collected from the bronchial epithelial lining fluid by microdialysis. The method with examination of the bronchial epithelial lining fluid by microdialysis and analysis of multiple inflammation markers as previously done by the investigators group.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients assigned for elective open aortic surgery are enrolled by invitation
Key inclusion criteria (1 listed)
- Patients assigned for elective open aortic surgery
Key exclusion criteria (1 listed)
- Moderate to severe COPD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cytokines in bronchial epithelial lining fluid
Time frame: Within 4 days of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
- Background: PubMed 20354465Tyvold SS, Solligard E, Gunnes S, Lyng O, Johannisson A, Gronbech JE, Aadahl P. Bronchial microdialysis of cytokines in the epithelial lining fluid in experimental intestinal ischemia and reperfusion before onset of manifest lung injury. Shock. 2010 Nov;34(5):517-24. doi: 10.1097/SHK.0b013e3181dfc430.
- Results publication: PubMed 28743822Tyvold SS, Dahl T, Dragsund S, Gunnes S, Lyng O, Damas JK, Aadahl P, Solligard E. Bronchial microdialysis monitoring of inflammatory response in open abdominal aortic aneurysm repair; an observational study. Physiol Rep. 2017 Jul;5(14):e13348. doi: 10.14814/phy2.13348.
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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.
Erik Solligård, md phd principal investigator
Norwegian University of Science and Technology
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 Acute Lung Injury, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 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: finished, as of the sponsor's last update on 21 Sep 2017. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokines in bronchial epithelial lining fluid (time frame: Within 4 days of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01322295, which also lists 2 linked publications.
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 21 Sep 2017.