Hemadsorption During and After Cardiopulmonary Bypass to Modulate the Inflammatory Response

University Magna Graecia40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Inflammatory Response Chronic Renal Disease

Interventions

CytoSorbDEVICE

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.

ControlDEVICE

No hemadsorption filter or other treatment will be included in the CPB circuit

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

AOU Mater Domini

Catanzaro, CZ, Italy

Outcomes

Primary Outcomes

IL-6 concentration at ICU admission

Investigators will assess the blood IL-6 concentrations between the two arms

Time frame: At day 0 after surgery

Secondary Outcomes

IL-6 concentration before cardiac surgery

Investigators will assess the blood IL-6 concentrations between the two arms

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 48 hours after the end of CardioPulmonary Bypass

Renal function

Investigators will assess the blood creatinine concentrations in the two arms