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Hemadsorption During and After Cardiopulmonary Bypass to Modulate the Inflammatory Response (IMHeS)

U

University Magna Graecia

Status

Unknown

Conditions

Cardiac Surgery
Chronic Renal Disease
Inflammatory Response

Treatments

Device: CytoSorb
Device: Control

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Giuseppe F Serraino, MD

Data sourced from clinicaltrials.gov

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