Acute Lung Injury After Aortic Valve Surgery | NCT01184313

Studies
Acute Lung Injury After Aortic Valve Surgery

NCT01184313

Sponsor

University of Oulu

Status

Unknown status

Last Update Posted

Sep 3, 2010Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Lung Injury

Interventions

aortic valve surgery with CPB

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 17, 2010

First Submission Date that Met QC Criteria

Aug 17, 2010

First Posted Date

Aug 18, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2010

Last Update Posted Date

Sep 3, 2010Estimated

Description Module

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?

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
aortic valve surgery			Procedure: aortic valve surgery with CPB

Interventions

Name	Type	Description	Arm Group Labels	Other Names
aortic valve surgery with CPB	Procedure	elective aortic valve surgery with CPB	aortic valve surgery

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elective aortic valve surgery patient
written consent

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

elective aortic valve surgery patients in Oulu University hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fausto Biancari, MD, PhD	Contact			fausto.biancari@ppshp.fi

Overall Officials

Name	Affiliation	Role
Reija Mikkola, MS	Oulu University Hospital	Principal Investigator
Fausto Biancari, MD, PhD	Oulu University Hospital	Study Director
Juha Koskenkari, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oulu University hospital		Oulu		90029	Finland

Condition Browse Module

MeSH Terms

ID	Term
D055370	Lung Injury

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D013898	Thoracic Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided