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Clinical Trials/NCT01187004
NCT01187004
Completed
Not Applicable

Extracardiac Complications After Cardiopulmonary by Pass in Cardiac Surgery

University of Turin, Italy1 site in 1 country164 target enrollmentStarted: April 2007Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
University of Turin, Italy
Enrollment
164
Locations
1
Primary Endpoint
Acute Lung Injury After Cardiac Surgery

Overview

Brief Summary

Hypothesis of the study is that patients undergoing major cardiac surgery can develop extracardiac complications correlated to cardiopulmonary by pass.

Detailed Description

To find out which are the main peri operative predictors of acute lung injury and other extracardiac complications, such as kidney injury, that prolonged Intensive Care Unit (ICU) length of stay after cardiac surgery. The main goal is to evaluate whether mechanical ventilation, in particular tidal volume, can be predictor of acute lung injure in this kind of patients.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • cardiac intervention with cardiopulmonary by pass, age \> 18 years old

Exclusion Criteria

  • off-pump surgery, heart and lung transplantations, patients on mechanical ventilation before intervention or admitted to Intensive Care Unit (ICU) before intervention.

Outcomes

Primary Outcomes

Acute Lung Injury After Cardiac Surgery

Time Frame: at seven days after intervention

to evaluate the incidence of acute lung injury (ALI) in patients undergoing cardiac surgery with cardiopulmonary by pass and to identify the main predictors.Diagnosis of Acute Lung Injury (ALI) was made according to the American-European Consensus conference criteria, including acute onset, PaO2 /FiO2 \<300 regardless of Positive End Expiratory Pressure (PEEP) level, bilateral and diffuse opacities on chest radiograph, absence of left ventricular failure, or history of lung disease.

Secondary Outcomes

  • Intensive Care Unit (ICU) Length of Stay(at 28 days)

Investigators

Sponsor
University of Turin, Italy
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Daniela Pasero

MD

University of Turin, Italy

Study Sites (1)

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