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Acute Lung Injury After Aortic Valve Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2010 by University of Oulu.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by:
University of Oulu
ClinicalTrials.gov Identifier:
NCT01184313
First received: August 17, 2010
Last updated: September 2, 2010
Last verified: August 2010
  Purpose

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?

Condition Intervention
Lung Injury
Procedure: aortic valve surgery with CPB

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Acute Lung Injury After Aortic Valve Surgery

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • lung injury [ Time Frame: within the first 3 days after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2010
Groups/Cohorts Assigned Interventions
aortic valve surgery Procedure: aortic valve surgery with CPB
elective aortic valve surgery with CPB

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
elective aortic valve surgery patients in Oulu University hospital
Criteria

Inclusion Criteria:

  • elective aortic valve surgery patient
  • written consent

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01184313

Locations
Finland
Oulu University hospital
Oulu, Finland, 90029
Sponsors and Collaborators
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
  More Information

Responsible Party: Reija Mikkola/MS, Oulu University
ClinicalTrials.gov Identifier: NCT01184313     History of Changes
Other Study ID Numbers: Mikkola2010 
Study First Received: August 17, 2010
Last Updated: September 2, 2010
Health Authority: Finland: Ministry of Social Affairs and Health

Keywords provided by University of Oulu:
aortic valve surgery
CPB
lung injury

Additional relevant MeSH terms:
Wounds and Injuries
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Thoracic Injuries

ClinicalTrials.gov processed this record on December 02, 2016