Hemadsorption During and After Cardiopulmonary Bypass to Modulate the Inflammatory Response

Not Applicable

• Conditions: Chronic Renal Disease; Cardiac Surgery; Inflammatory Response
• Interventions: Device: Control; Device: CytoSorb

• Registration Number: NCT04157647
• Lead Sponsor: University Magna Graecia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-13
• Study First Submitted QC: 2019-11-07
• Study First Posted: 2019-11-08
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-10
• Last Update Posted: 2020-11-12
• Study Start: 2020-11-15
• Primary Completion: 2021-11-01
• Study Completion: 2021-11-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Patients assigned to this arm group will undergo to a normal CPB without the use of any hemoadsorption system.
CytoSorb	CytoSorb	Patients assigned to this arm group will receive hemadsorption witbhCytoSorb during the surgery and in the next 24 hours after surgery.

Primary Outcome Measures

Name	Time	Method
IL-6 concentration at ICU admission	At day 0 after surgery	Investigators will assess the blood IL-6 concentrations between the two arms

Secondary Outcome Measures

Name	Time	Method
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
Liver transaminases concentration	daily up to day 15	Investigators will measure the liver transaminases concentrations in the two arms to assess any liver injury
Haptoglobin concentration	daily up to day 15	Investigators will assess the blood haptoglobin concentrations in the two arms
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 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
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
Renal function	daily up to day 15	Investigators will assess the blood creatinine concentrations in the two arms
Myoglobin concentration	daily up to day 15	Investigators will assess the blood myoglobin concentrations in the two arms
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

Trial Locations

Locations (1)

AOU Mater Domini; 🇮🇹 Catanzaro, CZ, Italy