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NCT01322295 Clinical Trial

Human Bronchial Microdialysis in Open Aortic Aneurysm Repair

Acute Lung Injury Clinical Trial

Official title:
Human Bronchial Microdialysis in Open Aortic Aneurysm Repair

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01322295
Other study ID # 2010/1649a
Secondary ID
Status Completed
Phase N/A
First received March 23, 2011
Last updated September 19, 2017
Start date March 2011
Est. completion date December 2011

Study information
Verified date September 2017
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date December 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients assigned for elective open aortic surgery

Exclusion Criteria:

- Moderate to severe COPD

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Norway St. Olavs Hospital Trondheim

Sponsors (2)
Lead Sponsor Collaborator
Norwegian University of Science and Technology St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Tyvold SS, Dahl T, Dragsund S, Gunnes S, Lyng O, Damås JK, Aadahl P, Solligård E. Bronchial microdialysis monitoring of inflammatory response in open abdominal aortic aneurysm repair; an observational study. Physiol Rep. 2017 Jul;5(14). pii: e13348. doi: — View Citation

Tyvold SS, Solligård E, Gunnes S, Lyng O, Johannisson A, Grønbech 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Cytokines in bronchial epithelial lining fluid Within 4 days of surgery
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