Clinical trial NCT04157647: Hemadsorption During and After Cardiopulmonary Bypass to Modulate the Inflammatory Response
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Response
Chronic Renal Disease
Cardiac Surgery
Keywords: hemadsorption
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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 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.

Primary outcomes:
measure: IL-6 concentration at ICU admission
timeFrame: At day 0 after surgery
Secondary outcomes:
measure: IL-6 concentration before cardiac surgery
timeFrame: At day 0 before the cardiac surgery
measure: IL-6 concentration at the end of CardioPulmonary Bypass
timeFrame: At day 0 at the end of the CardioPulmonary Bypass
measure: IL-6 concentration 2 hours after the end of CardioPulmonary Bypass
timeFrame: 2 hours after the end of CardioPulmonary Bypass
measure: IL-6 concentration 48 hours after the end of CardioPulmonary Bypass
timeFrame: 48 hours after the end of CardioPulmonary Bypass
measure: Renal function
timeFrame: daily up to day 15
measure: Myoglobin concentration
timeFrame: daily up to day 15
measure: Haptoglobin concentration
timeFrame: daily up to day 15
measure: Liver transaminases concentration
timeFrame: daily up to day 15
measure: Osteopontin concentration
timeFrame: daily up to day 15
measure: Free hemoglobin concentration
timeFrame: daily up to day 15
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: AOU Mater Domini
state: CZ
Study officials:
affiliation: Magna Graecia University
name: Giuseppe Serraino, MD
role: PRINCIPAL_INVESTIGATOR
References:
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