NCT01184313

Brief 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?

Trial Health

55
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Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2010

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
Last Updated

September 3, 2010

Status Verified

August 1, 2010

First QC Date

August 17, 2010

Last Update Submit

September 2, 2010

Conditions

Lung Injury

Keywords

aortic valve surgeryCPBlung injury

Outcome Measures

Primary Outcomes (1)

  • lung injury

    within the first 3 days after surgery

Study Arms (1)

aortic valve surgery

Procedure: aortic valve surgery with CPB

Interventions

aortic valve surgery with CPBPROCEDURE

elective aortic valve surgery with CPB

aortic valve surgery

Eligibility Criteria

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

elective aortic valve surgery patients in Oulu University hospital

You may qualify if:

  • elective aortic valve surgery patient
  • written consent

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University hospital

Oulu, 90029, Finland

Location

MeSH Terms

Conditions

Lung Injury

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesThoracic InjuriesWounds and Injuries

Study Officials

  • Reija Mikkola, MS

    Oulu University Hospital

    PRINCIPAL INVESTIGATOR

  • Fausto Biancari, MD, PhD

    Oulu University Hospital

    STUDY DIRECTOR

  • Juha Koskenkari, MD

    Oulu University Hospital

    STUDY CHAIR

  • Vesa Pakanen, MD

    Oulu University Hospital

    STUDY CHAIR

  • Tatu Juvonen, prof.

    Oulu University Hospital

    STUDY CHAIR

Central Study Contacts

Fausto Biancari, MD, PhD

CONTACT

fausto.biancari@ppshp.fi

Study Design

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

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 18, 2010

Study Start

September 1, 2010

Last Updated

September 3, 2010

Record last verified: 2010-08

Locations

FI(1)