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Trial record 26 of 36 for:    Cytosorb

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

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ClinicalTrials.gov Identifier: NCT04157647
Recruitment Status : Not yet recruiting
First Posted : November 8, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
GIUSEPPE FILIBERTO SERRAINO, 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.

Condition or disease Intervention/treatment Phase
Inflammatory Response Chronic Renal Disease Cardiac Surgery Device: CytoSorb Device: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 15, 2020

Arm Intervention/treatment
Active Comparator: CytoSorb
Patients assigned to this arm group will receive hemadsorption witbhCytoSorb during the surgery and in the next 24 hours after surgery.
Device: CytoSorb
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.

Sham Comparator: Control
Patients assigned to this arm group will undergo to a normal CPB without the use of any hemoadsorption system.
Device: Control
No hemadsorption filter or other treatment will be included in the CPB circuit




Primary Outcome Measures :
  1. IL-6 concentration at ICU admission [ Time Frame: At day 0 after surgery ]
    Investigators will assess the blood IL-6 concentrations between the two arms


Secondary Outcome Measures :
  1. IL-6 concentration before cardiac surgery [ Time Frame: At day 0 before the cardiac surgery ]
    Investigators will assess the blood IL-6 concentrations between the two arms

  2. IL-6 concentration at the end of CardioPulmonary Bypass [ Time Frame: At day 0 at the end of the CardioPulmonary Bypass ]
    Investigators will assess the blood IL-6 concentrations between the two arms

  3. IL-6 concentration 2 hours after the end of CardioPulmonary Bypass [ Time Frame: 2 hours after the end of CardioPulmonary Bypass ]
    Investigators will assess the blood IL-6 concentrations between the two arms

  4. IL-6 concentration 48 hours after the end of CardioPulmonary Bypass [ Time Frame: 48 hours after the end of CardioPulmonary Bypass ]
    Investigators will assess the blood IL-6 concentrations between the two arms

  5. Renal function [ Time Frame: daily up to day 15 ]
    Investigators will assess the blood creatinine concentrations in the two arms

  6. Myoglobin concentration [ Time Frame: daily up to day 15 ]
    Investigators will assess the blood myoglobin concentrations in the two arms

  7. Haptoglobin concentration [ Time Frame: daily up to day 15 ]
    Investigators will assess the blood haptoglobin concentrations in the two arms

  8. Liver transaminases concentration [ Time Frame: daily up to day 15 ]
    Investigators will measure the liver transaminases concentrations in the two arms to assess any liver injury

  9. Osteopontin concentration [ Time Frame: daily up to day 15 ]
    Investigators will measure the osteopontin concentrations in the two arms to assess the inflammatory status

  10. Free hemoglobin concentration [ Time Frame: daily up to day 15 ]
    Investigators will assess the free hemoglobin concentrations in the two arms



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04157647


Contacts
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Contact: Giuseppe F Serraino, MD 0039 0961 3647033 filiberto@live.it

Locations
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Italy
AOU Mater Domini
Catanzaro, CZ, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
Investigators
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Principal Investigator: Giuseppe Serraino, MD Magna Graecia University

Publications:

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Responsible Party: GIUSEPPE FILIBERTO SERRAINO, Principal Investigator, University Magna Graecia
ClinicalTrials.gov Identifier: NCT04157647    
Other Study ID Numbers: IMHeS
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The full protocol, datasets used and analysed during the current study will be available on reasonable request after study publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: After scientific publication
Access Criteria: On reasonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by GIUSEPPE FILIBERTO SERRAINO, University Magna Graecia:
hemadsorption
Additional relevant MeSH terms:
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Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency