Acute Kidney Injury, Cardiac Disease, Extracorporeal Circulation; Complications, Perfusion; Complications
Conditions
Keywords
acute kidney injury, cardiopulmonary bypass, cardiac surgery, risk score
Brief summary
Cardiac surgery-associated acute kidney injury (CSA-AKI) is a frequent complication after cardiac operations with cardiopulmonary bypass (CPB) use. Its frequency varies depending on the severity grade. There are different static predictive scores for the CSA-AKI based on the patient and surgery-associated parameters. Recently, in our Institution was developed a predictive algorithm for CSA-AKI that starts with a static model and then integrated with 7 CPB-associated parameters: HCT, DO2, time of exposure to a critical DO2, systemic pressure, CPB duration time, lactate value, transfusion of red blood cells (RBC), that together build a dynamic perfusion risk (DPR) associated to the CPB. Combining the static and dynamic models produces the Multifactorial Dynamic Perfusion Index (MDPI). The present study validates MDPI in a new prospective series of patients undergoing cardiac surgery with CPB.
Detailed description
Cardiac surgery-associated acute kidney injury (CSA-AKI) is a frequent complication after cardiac operations with cardiopulmonary bypass (CPB) use. Its frequency varies depending on the severity grade which for the present study follows the AKIN criteria. There are different predictive scores for the CSA-AKI based on the patient and surgery-associated parameters. These models could be defined as static. It's known that a number of CPB-associated parameters could influence CSA-AKI, as well. These include hematocrit (HCT), oxygen delivery (DO2), time of exposure to a critical DO2, and perfusion pressure. These parameters, taken separately, are associated with CSA-AKI development. Recently, our Institution has developed a predictive algorithm for CSA-AKI that starts with a static model and then integrated with 7 CPB-associated parameters: HCT, DO2, time of exposure to a critical DO2, systemic pressure, CPB duration time, lactate value, transfusion of red blood cells (RBC), that together build a dynamic perfusion risk (DPR) associated to the CPB. Combining the static and dynamic models produces the Multifactorial Dynamic Perfusion Index (MDPI). MDPI has higher discrimination power when compared to the static scores, in the original series and in the internal validation with the Bootstrap technique. The present study validates MDPI in a new prospective series of patients undergoing cardiac surgery with CPB. An enrollment of 400 patients is anticipated with a stopping rule for efficacy at interim analysis (for primary endpoint) at 50% enrollment (200 patients) if the c-statistics for any stage of CSA-AKI reaches at least 0.75. Futility is defined as an AUC of 0.6 or lower.
Interventions
OTHERPEQUOD
During cardiopulmonary bypass registration of the parameters of interest by the Livanova BE-CAPTA monitor. After surgery, registration of creatinine values up to 48 postoperative hours.
Sponsors
IRCCS Policlinico S. Donato
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients undergoing cardiac surgery with cardiopulmonary bypass * age of 18 years and higher * willingness to participate and sign the informed consent
Exclusion criteria
\- patients requiring preoperative dialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with postoperative acute kidney injury | First 48 postoperative hours | Occurence of any stage acute kidney injury as defined by the AKIN criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of deceased patients | 30 days after surgery | Dead or alive status |
| Number of patients with postoperative respiratory insufficiency | First 48 postoperative hours | P/F ratio \> 200 with radiographic evidence of pulmonary distress, if compared to the baseline by an independent radiologist |
| Number of patients with postoperative low cardiac output | First 48 postoperative hours | Use of inotrope drugs for more than 48 hours and/or mechanical support |
| Number of patients experiencing postoperative major morbidity | First 48 postoperative hours | As defined by STS criteria as one or more of the following items: AKI stage 2, stroke, mechanical ventilation duration \> 48 hours, sepsis, surgical re-exploration |
| Number of patients who needed prolonged ICU stay | First 4 postoperative days | ICU stay duration \> 4 days |
Countries
Italy
Contacts
Primary ContactMarco Ranucci, MD
Outcome results
None listed