Human Bronchial Microdialysis in Open Aortic Aneurysm Repair

This study has been completed.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01322295
First received: March 23, 2011
Last updated: August 8, 2012
Last verified: August 2012

March 23, 2011
August 8, 2012
March 2011
November 2011   (final data collection date for primary outcome measure)
Cytokines in bronchial epithelial lining fluid [ Time Frame: Within 4 days of surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01322295 on ClinicalTrials.gov Archive Site
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Human Bronchial Microdialysis in Open Aortic Aneurysm Repair
Human Bronchial Microdialysis in Open Aortic Aneurysm Repair

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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Patients assigned for elective open aortic surgery are enrolled by invitation

Acute Lung Injury
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
December 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients assigned for elective open aortic surgery

Exclusion Criteria:

  • Moderate to severe COPD
Both
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No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01322295
2010/1649a
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
St. Olavs Hospital
Principal Investigator: Stig S Tyvold, cand med Norwegian University of Science and Technology
Norwegian University of Science and Technology
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP