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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
History of Changes
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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: Stig S Tyvold, cand med Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01322295     History of Changes
Other Study ID Numbers: 2010/1649a
Study First Received: March 23, 2011
Last Updated: August 8, 2012
Health Authority: Norway: Directorate of Health
Norway: Norwegian Social Science Data Services
Norway: Regional Ethics Commitee
Norway:National Committee for Medical and Health Research Ethics

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

ClinicalTrials.gov processed this record on May 19, 2013