CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery

Study Overview
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Brief Summary
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Prospective, multi-center, randomized, blinded, pivotal clinical study. Subjects will be randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care plus treatment with the CytoSorb® device.

Official Title
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CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery (REFRESH II Trial)

Conditions
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Elective Cardiac Surgery

Intervention / Treatment
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* Device: CytoSorb


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for non-emergent cardiac surgery requiring CPB for i) heart valve replacement with any other procedure, without hypothermic circulatory arrest (HCA), or ii) aortic reconstruction with or without another procedure, with HCA Exclusion Criteria: Isolated Coronary Artery Bypass Graft Pregnant women Life expectancy of < 14 days End stage organ disease Active infection Correction of a congenital heart defect Contraindication to anticoagulation with heparin Minimally invasive surgery implantation (TAVI) or transcatheter aortic valve replacement (TAVR) Declined informed consent

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CytoSorb Device<br>Standard of care plus treatment with CytoSorb device installed on the Cardiopulmonary bypass (CPB) machine | Device: CytoSorb<br>* To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI)<br>* Other names: CytoSorb device used during cardiopulmonary bypass (CPB);|
| Placebo Comparator: Control<br>Standard of care | Device: CytoSorb<br>* To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI)<br>* Other names: CytoSorb device used during cardiopulmonary bypass (CPB);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence or severity of acute kidney injury (AKI) in the first 48 hours after cardiopulmonary pulmonary bypass (CPB) | Kidney Disease Improving Global Outcomes (KDIGO) definitions for AKI | From start of CPB through 48 hours after CPB | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in maximum plasma free hemoglobin and activated complement from start of CPB through post-surgery day 3 | Blood sample indices of effects from cardiac surgery with CPB | From start of CPB through post-surgery day 3 | 
| Severity or duration of AKI in the first 7 days after CPB | KDIGO definitions for AKI | From start of CPB through 7 days post-cardiac surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CytoSorb device, Plasma free hemoglobin, inflammation, extracorporeal cardiopulmonary bypass, cardiopulmonary bypass, Acute Kidney Injury