Extracardiac Complications After Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01187004
Recruitment Status : Completed
First Posted : August 23, 2010
Results First Posted : January 6, 2012
Last Update Posted : February 12, 2013
Information provided by (Responsible Party):
Daniela Pasero, University of Turin, Italy

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

Condition or disease
Acute Lung Injury Sepsis Infections Acute Kidney Injury

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 Type : Observational
Actual Enrollment : 164 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Extracardiac Complications After Cardiopulmonary by Pass in Cardiac Surgery
Study Start Date : April 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2009

Acute Lung Injury (ALI)
patients who might develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Intensive Care Unit (ICU) Length of Stay [ Time Frame: at 28 days ]
    If extracardiac complications, especially acute lung injury, prolonged Intensive Care Unit (ICU) length of stay due to longer mechanical ventilation.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients undergoing major cardiac surgery with cardiopulmonary by pass

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01187004

Cardiac Intensive Care Unit, San Giovanni Battista Hospital
Turin, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy
Study Chair: Mauro Rinaldi, MD San Giovanni Battista Hospital, University of Turin

Responsible Party: Daniela Pasero, MD, University of Turin, Italy Identifier: NCT01187004     History of Changes
Other Study ID Numbers: 82755
First Posted: August 23, 2010    Key Record Dates
Results First Posted: January 6, 2012
Last Update Posted: February 12, 2013
Last Verified: February 2013

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