Cardiac Surgery, Chronic Renal Disease, Inflammatory Response
Conditions
Keywords
hemadsorption
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.
Interventions
DEVICECytoSorb
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.
DEVICEControl
No hemadsorption filter or other treatment will be included in the CPB circuit
Sponsors
University Magna Graecia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IL-6 concentration at ICU admission | At day 0 after surgery | Investigators will assess the blood IL-6 concentrations between the two arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IL-6 concentration at the end of CardioPulmonary Bypass | At day 0 at the end of the CardioPulmonary Bypass | Investigators will assess the blood IL-6 concentrations between the two arms |
| IL-6 concentration 2 hours after the end of CardioPulmonary Bypass | 2 hours after the end of CardioPulmonary Bypass | Investigators will assess the blood IL-6 concentrations between the two arms |
| IL-6 concentration 48 hours after the end of CardioPulmonary Bypass | 48 hours after the end of CardioPulmonary Bypass | Investigators will assess the blood IL-6 concentrations between the two arms |
| Renal function | daily up to day 15 | Investigators will assess the blood creatinine concentrations in the two arms |
| IL-6 concentration before cardiac surgery | At day 0 before the cardiac surgery | Investigators will assess the blood IL-6 concentrations between the two arms |
| Haptoglobin concentration | daily up to day 15 | Investigators will assess the blood haptoglobin concentrations in the two arms |
| Liver transaminases concentration | daily up to day 15 | Investigators will measure the liver transaminases concentrations in the two arms to assess any liver injury |
| Osteopontin concentration | daily up to day 15 | Investigators will measure the osteopontin concentrations in the two arms to assess the inflammatory status |
| Free hemoglobin concentration | daily up to day 15 | Investigators will assess the free hemoglobin concentrations in the two arms |
| Myoglobin concentration | daily up to day 15 | Investigators will assess the blood myoglobin concentrations in the two arms |
Countries
Italy
Contacts
Primary ContactGiuseppe F Serraino, MD
Outcome results
None listed