Extracardiac Complications After Cardiac Surgery
This study has been completed.
Sponsor:
University of Turin, Italy
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
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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
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:
|
Acute Kidney Injury Sepsis Acute Lung Injury Respiratory Distress Syndrome, Adult Lung Injury Renal Insufficiency Kidney Diseases Urologic Diseases Infection |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Lung Diseases Respiratory Tract Diseases Respiration Disorders Thoracic Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013