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Human Bronchial Microdialysis in Open Aortic Aneurysm Repair

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01322295
First Posted: March 24, 2011
Last Update Posted: September 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose

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.


Condition
Acute Lung Injury

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Human Bronchial Microdialysis in Open Aortic Aneurysm Repair

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Cytokines in bronchial epithelial lining fluid [ Time Frame: Within 4 days of surgery ]

Enrollment: 16
Actual Study Start Date: March 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients assigned for elective open aortic surgery are enrolled by invitation
Criteria

Inclusion Criteria:

  • Patients assigned for elective open aortic surgery

Exclusion Criteria:

  • Moderate to severe COPD
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322295


Locations
Norway
St. Olavs Hospital
Trondheim, Norway, N-7024
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Principal Investigator: Erik Solligård, md phd Norwegian University of Science and Technology
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01322295     History of Changes
Other Study ID Numbers: 2010/1649a
First Submitted: March 23, 2011
First Posted: March 24, 2011
Last Update Posted: September 21, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Respiration Disorders