Extracardiac Complications After Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniela Pasero, University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT01187004
First received: August 19, 2010
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

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


Condition
Acute Lung Injury
Sepsis
Infections
Acute Kidney Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Extracardiac Complications After Cardiopulmonary by Pass in Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • Acute Lung Injury After Cardiac Surgery [ Time Frame: at seven days after intervention ] [ Designated as safety issue: No ]
    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:
  • Intensive Care Unit (ICU) Length of Stay [ Time Frame: at 28 days ] [ Designated as safety issue: No ]
    If extracardiac complications, especially acute lung injury, prolonged Intensive Care Unit (ICU) length of stay due to longer mechanical ventilation.


Enrollment: 164
Study Start Date: April 2007
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acute Lung Injury (ALI)
patients who might develop acute lung injury (ALI) after cardiac surgery with 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients undergoing major cardiac surgery with cardiopulmonary by pass

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01187004

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

No publications provided

Responsible Party: Daniela Pasero, MD, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT01187004     History of Changes
Other Study ID Numbers: 82755
Study First Received: August 19, 2010
Results First Received: August 8, 2011
Last Updated: February 5, 2013
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on September 16, 2014