PErfusion QUality ODds

Study Overview
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Brief Summary
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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
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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.

Official Title
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Perfusion Quality Odds

Conditions
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Cardiac Disease, Extracorporeal Circulation; Complications, Perfusion; Complications, Acute Kidney Injury

Intervention / Treatment
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* Other: PEQUOD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PEQUOD<br>Patients undergoing cardiac surgery with cardiopulmonary bypass whose parameters of interest will be registered during cardiopulmonary bypass by the Livanova BE-CAPTA monitor. | Other: PEQUOD<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with postoperative acute kidney injury | Occurence of any stage acute kidney injury as defined by the AKIN criteria | First 48 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with postoperative respiratory insufficiency | P/F ratio > 200 with radiographic evidence of pulmonary distress, if compared to the baseline by an independent radiologist | First 48 postoperative hours | 
| Number of patients with postoperative low cardiac output | Use of inotrope drugs for more than 48 hours and/or mechanical support | First 48 postoperative hours | 
| Number of patients experiencing postoperative major morbidity | 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 | First 48 postoperative hours | 
| Number of patients who needed prolonged ICU stay | ICU stay duration > 4 days | First 4 postoperative days | 
| Number of deceased patients | Dead or alive status | 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute kidney injury, cardiopulmonary bypass, cardiac surgery, risk score