Acute Lung Injury After Aortic Valve Surgery

September 2, 2010 updated by: University of Oulu

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?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
      • Oulu, Finland, 90029
        • Oulu University Hospital
        • Contact:
        • Principal Investigator:
          • Reija Mikkola, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

elective aortic valve surgery patients in Oulu University hospital

Description

Inclusion Criteria:

  • elective aortic valve surgery patient
  • written consent

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
aortic valve surgery
Procedure: aortic valve surgery with CPB
elective aortic valve surgery with CPB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
lung injury
Time Frame: within the first 3 days after surgery
within the first 3 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Investigators

  • Principal Investigator: Reija Mikkola, MS, Oulu University Hospital
  • Study Director: Fausto Biancari, MD, PhD, Oulu University Hospital
  • Study Chair: Juha Koskenkari, MD, Oulu University Hospital
  • Study Chair: Vesa Pakanen, MD, Oulu University Hospital
  • Study Chair: Tatu Juvonen, prof., Oulu University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Study Registration Dates

First Submitted

August 17, 2010

First Submitted That Met QC Criteria

August 17, 2010

First Posted (Estimate)

August 18, 2010

Study Record Updates

Last Update Posted (Estimate)

September 3, 2010

Last Update Submitted That Met QC Criteria

September 2, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mikkola2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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