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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Inflammatory Response
- Sponsor
- University Magna Graecia
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- IL-6 concentration at ICU admission
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
GIUSEPPE FILIBERTO SERRAINO
Principal Investigator
University Magna Graecia
Eligibility Criteria
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 m
- •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.
Outcomes
Primary Outcomes
IL-6 concentration at ICU admission
Time Frame: At day 0 after surgery
Investigators will assess the blood IL-6 concentrations between the two arms
Secondary Outcomes
- IL-6 concentration before cardiac surgery(At day 0 before the cardiac surgery)
- Liver transaminases concentration(daily up to day 15)
- Haptoglobin concentration(daily up to day 15)
- IL-6 concentration at the end of CardioPulmonary Bypass(At day 0 at the end of the CardioPulmonary Bypass)
- IL-6 concentration 48 hours after the end of CardioPulmonary Bypass(48 hours after the end of CardioPulmonary Bypass)
- IL-6 concentration 2 hours after the end of CardioPulmonary Bypass(2 hours after the end of CardioPulmonary Bypass)
- Renal function(daily up to day 15)
- Myoglobin concentration(daily up to day 15)
- Osteopontin concentration(daily up to day 15)
- Free hemoglobin concentration(daily up to day 15)