Acute Kidney Injury, Acute Lung Injury, Infections, Sepsis
Conditions
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.
Interventions
None listed
Sponsors
University of Turin, Italy
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Lung Injury After Cardiac Surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Intensive Care Unit (ICU) Length of Stay | at 28 days | If extracardiac complications, especially acute lung injury, prolonged Intensive Care Unit (ICU) length of stay due to longer mechanical ventilation. |
Countries
Italy
Participant flow
Recruitment details
We enrolled all patients undergoing a cardiac surgery intervention on cardiopulmonary by pass (CPB)
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Acute Lung Injury (ALI) Group patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass | 20 |
| Control Group patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass | 144 |
| Total | 164 |
Baseline characteristics
| Characteristic | Control Group | Acute Lung Injury (ALI) Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 87 Participants | 13 Participants | 100 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants | 7 Participants | 64 Participants |
| Age Continuous | 65 years STANDARD_DEVIATION 14 | 69 years STANDARD_DEVIATION 10 | 66 years STANDARD_DEVIATION 13 |
| Region of Enrollment Italy | 144 participants | 20 participants | 164 participants |
| Sex: Female, Male Female | 38 Participants | 9 Participants | 47 Participants |
| Sex: Female, Male Male | 106 Participants | 11 Participants | 117 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 144 |
| serious Total, serious adverse events | 0 / 20 | 0 / 144 |
Outcome results
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.
Time frame: at seven days after intervention
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acute Lung Injury | Acute Lung Injury After Cardiac Surgery | 20 participants |
Comparison: Our hypothesis was that mechanical ventilation with large tidal volume might represent a risk factor for acute lung injury in patients undergoing cardiopulmonary bypass.p-value: <0.05Regression, Logistic
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.
Time frame: at 28 days
Population: 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
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Acute Lung Injury | Intensive Care Unit (ICU) Length of Stay | 22 days | Inter-Quartile Range 54 |
| Control Group | Intensive Care Unit (ICU) Length of Stay | 2 days | — |
p-value: <0.00195% CI: [1.129, 1.272]Wilcoxon (Mann-Whitney)