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NCT01184313 Clinical Trial

Acute Lung Injury After Aortic Valve Surgery

Lung Injury Clinical Trial

Official title:
Acute Lung Injury After Aortic Valve Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01184313
Other study ID # Mikkola2010
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 17, 2010
Last updated September 2, 2010
Start date September 2010

Study information
Verified date August 2010
Source University of Oulu
Contact Fausto Biancari, MD, PhD
Email fausto.biancari@ppshp.fi
Is FDA regulated No
Health authority Finland: Ministry of Social Affairs and Health
Study type Observational

Clinical Trial Summary

The purpose of this prospective, randomized clinical trial is to understand and measure lung injuries caused by CPB in aortic valve surgery.

Study questions:

- Is there any correlation between the release of pro-inflammatory biomarkers and lung injury degree?

- Is there any correlation between oxyhaemodynamic parameters and lung injury degree?

- Is there any correlation between oxyhaemodynamic parameters and the release of pro-inflammatory biomarkers?

- Are budesonide, erdostein and acetylcystein effective in the prevention of lung injuries?

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- elective aortic valve surgery patient

- written consent

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• aortic valve surgery with CPB
elective aortic valve surgery with CPB

Locations
Country Name City State
Finland Oulu University hospital Oulu

Sponsors (1)
Lead Sponsor Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary lung injury within the first 3 days after surgery No
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