NCT01322295

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 21, 2017

Status Verified

September 1, 2017

Enrollment Period

8 months

First QC Date

March 23, 2011

Last Update Submit

September 19, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cytokines in bronchial epithelial lining fluid

    Within 4 days of surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients assigned for elective open aortic surgery are enrolled by invitation

You may qualify if:

  • Patients assigned for elective open aortic surgery

You may not qualify if:

  • Moderate to severe COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs Hospital

Trondheim, N-7024, Norway

Location

Related Publications (2)

  • 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.

    PMID: 20354465BACKGROUND
  • Tyvold 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.

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Erik Solligård, md phd

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2011

First Posted

March 24, 2011

Study Start

March 1, 2011

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

September 21, 2017

Record last verified: 2017-09

Locations