Hemadsorption During and After Cardiopulmonary Bypass to Modulate the Inflammatory Response

Study Overview
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Brief Summary
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Chronic kidney disease (CKD) is a risk factor for the development of cardiovascular disease, which increases the risk of death after cardiac surgery. High interleukin 6 (IL-6) blood levels is commonly observed in patients with CKD, and this is particularly high after cardiac surgery. High IL-6 levels are also associated with increased long-term mortality rate after cardiac surgery. To date, the use of ultrafiltration or endotoxin adsorption systems were not found to improve the clinical outcome, although able to reduce the inflammatory mediators concentrations. In the last years, a new extracorporeal hemadsorption filter (CytoSorb) has been developed for removal of inflammatory cytokines and it has been approved by the European Union. However, data lack about the impact on clinical outcome of the use of CytoSorb in patients with CKD undergoing cardiac surgery with cardio-pulmonary bypass (CPB). The investigators have therefore designed this pilot prospective randomized trial to evaluate the efficacy the intraoperative use of CytoSorb for cytokines removal to prevent the inflammatory response associated with the cardiac surgery and complications in patients with CKD.

Official Title
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Monocentric Prospective Randomized Pilot Study in Patients With Kidney Failure to Evaluate the Relationship Between the Hemadsorption During and After Cardiopulmonary Bypass and the Modulation of Post-surgical Inflammatory Response

Conditions
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Inflammatory Response, Chronic Renal Disease, Cardiac Surgery

Intervention / Treatment
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* Device: CytoSorb
* Device: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All consecutive adult patients (age >65 years) undergoing cardiac surgery with an anticipated CPB time duration longer than 60 minutes. Presence of CKD defined by a Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73 m2. Consent to participate to the study Exclusion Criteria: emergency surgery acute infective endocarditis systemic infectious diseases previous kidney transplant need for contrast enhancement during surgery immunosuppressive or long-term corticosteroid therapies participation to other investigations.

Ages Eligible for Study
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Minimum Age: 65 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CytoSorb<br>Patients assigned to this arm group will receive hemadsorption witbhCytoSorb during the surgery and in the next 24 hours after surgery. | Device: CytoSorb<br>* The hemadsorption filter will be included in the CPB circuit between the oxygenator and the venous reservoir. After cardiac surgery, the use of the filter will be continued till 24 hours after the end of surgery.<br>|
| Sham Comparator: Control<br>Patients assigned to this arm group will undergo to a normal CPB without the use of any hemoadsorption system. | Device: Control<br>* No hemadsorption filter or other treatment will be included in the CPB circuit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-6 concentration at ICU admission | Investigators will assess the blood IL-6 concentrations between the two arms | At day 0 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-6 concentration before cardiac surgery | Investigators will assess the blood IL-6 concentrations between the two arms | At day 0 before the cardiac surgery | 
| IL-6 concentration at the end of CardioPulmonary Bypass | Investigators will assess the blood IL-6 concentrations between the two arms | At day 0 at the end of the CardioPulmonary Bypass | 
| IL-6 concentration 2 hours after the end of CardioPulmonary Bypass | Investigators will assess the blood IL-6 concentrations between the two arms | 2 hours after the end of CardioPulmonary Bypass | 
| IL-6 concentration 48 hours after the end of CardioPulmonary Bypass | Investigators will assess the blood IL-6 concentrations between the two arms | 48 hours after the end of CardioPulmonary Bypass | 
| Renal function | Investigators will assess the blood creatinine concentrations in the two arms | daily up to day 15 | 
| Myoglobin concentration | Investigators will assess the blood myoglobin concentrations in the two arms | daily up to day 15 | 
| Haptoglobin concentration | Investigators will assess the blood haptoglobin concentrations in the two arms | daily up to day 15 | 
| Liver transaminases concentration | Investigators will measure the liver transaminases concentrations in the two arms to assess any liver injury | daily up to day 15 | 
| Osteopontin concentration | Investigators will measure the osteopontin concentrations in the two arms to assess the inflammatory status | daily up to day 15 | 
| Free hemoglobin concentration | Investigators will assess the free hemoglobin concentrations in the two arms | daily up to day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemadsorption