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Hypothesis of the study is that patients undergoing major cardiac surgery can develop extracardiac complications correlated to cardiopulmonary by pass.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Lung Injury (ALI) | patients who might develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass |
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| Measure | Description | Time Frame |
|---|---|---|
| Acute Lung Injury After Cardiac Surgery | 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. | at seven days after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive Care Unit (ICU) Length of Stay | If extracardiac complications, especially acute lung injury, prolonged Intensive Care Unit (ICU) length of stay due to longer mechanical ventilation. | at 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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patients undergoing major cardiac surgery with cardiopulmonary by pass
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| Name | Affiliation | Role |
|---|---|---|
| Mauro Rinaldi, MD | San Giovanni Battista Hospital, University of Turin | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiac Intensive Care Unit, San Giovanni Battista Hospital | Turin | Italy | 10126 | Italy |
Patients were excluded for: Intensive Care Unit - Length of stay (ICU-LOS)<24h, age < 18 yrs old; mechanical ventilation before surgery; Acute Lung Injury (ALI) at the admission to Intensive Care Unit (ICU); heart and lung transplant
We enrolled all patients undergoing a cardiac surgery intervention on cardiopulmonary by pass (CPB)
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| ID | Title | Description |
|---|---|---|
| FG000 | Acute Lung Injury (ALI) Group | patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass |
| FG001 | Control Group | patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acute Lung Injury (ALI) Group | patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass |
| BG001 | Control Group | patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acute Lung Injury After Cardiac Surgery | 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. | Patients consecutively admitted to the cardiac Intensive Care Unit (cICU) after cardiac surgery on cardiopulmonary by pass (CPB), during a time frame of two years.The analysis was per protocol, to identify the predictors of acute lung injury after cardiac surgery. | Posted | Number | participants | at seven days after intervention |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acute Lung Injury (ALI) Group | patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass |
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The main limitation of the trial was the observational nature and the relatively small number of patients
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Daniela Pasero | UTurin | 00390116335511 | daniela.pasero@unito.it |
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| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| D018805 | Sepsis |
| D007239 | Infections |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018746 | Systemic Inflammatory Response Syndrome |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients who developed acute lung injury (ALI) after cardiac surgery and during mechanical ventilation
|
|
|
| Secondary | Intensive Care Unit (ICU) Length of Stay | If extracardiac complications, especially acute lung injury, prolonged Intensive Care Unit (ICU) length of stay due to longer mechanical ventilation. | The analysis of the Intensive Care Unit (ICU) length of stay was done on all the patients included in the study. We want to evaluate if the development of acute lung injury prolongs the intensive care unit length of stay.ICU length of stay was calculated up to 28 days,and patients who died before were considered as having the maximum value | Posted | Median | Inter-Quartile Range | days | at 28 days |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Control Group | patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass | 0 | 144 | 0 | 144 |
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| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |