PErfusion QUality ODds

Recruiting

• Conditions: Extracorporeal Circulation; Complications; Perfusion; Complications; Cardiac Disease; Acute Kidney Injury
• Interventions: Other: PEQUOD

• Registration Number: NCT06019546
• Lead Sponsor: IRCCS Policlinico S. Donato

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.

Study Timeline

• Study Start: 2023-01-23
• Study First Submitted: 2023-08-25
• Study First Submitted QC: 2023-08-25
• Study First Posted: 2023-08-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PEQUOD	PEQUOD	Patients undergoing cardiac surgery with cardiopulmonary bypass whose parameters of interest will be registered during cardiopulmonary bypass by the Livanova BE-CAPTA monitor.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of deceased patients	30 days after surgery	Dead or alive status
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 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 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

Trial Locations

Locations (1)

IRCCS Policlinico San Donato; 🇮🇹 San Donato Milanese, MI, Italy