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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, 2020
Sponsor:
Information provided by (Responsible Party):
GIUSEPPE FILIBERTO SERRAINO, University Magna Graecia

Tracking Information
First Submitted Date  ICMJE October 13, 2019
First Posted Date  ICMJE November 8, 2019
Last Update Posted Date November 12, 2020
Estimated Study Start Date  ICMJE November 15, 2020
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
  • 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
  • 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
  • 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
  • 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
  • Renal function [ Time Frame: daily up to day 15 ]
    Investigators will assess the blood creatinine concentrations in the two arms
  • Myoglobin concentration [ Time Frame: daily up to day 15 ]
    Investigators will assess the blood myoglobin concentrations in the two arms
  • Haptoglobin concentration [ Time Frame: daily up to day 15 ]
    Investigators will assess the blood haptoglobin concentrations in the two arms
  • 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
  • Osteopontin concentration [ Time Frame: daily up to day 15 ]
    Investigators will measure the osteopontin concentrations in the two arms to assess the inflammatory status
  • Free hemoglobin concentration [ Time Frame: daily up to day 15 ]
    Investigators will assess the free hemoglobin concentrations in the two arms
Original Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
  • IL-6 concentration before cardiac surgery [ Time Frame: The morning before the cardiac surgery ]
    Investigators will assess the blood IL-6 concentrations between the two arms
  • IL-6 concentration at the end of CardioPulmonary Bypass [ Time Frame: At the end of the 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 [ Time Frame: 2 hours after the end of 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 [ Time Frame: 48 hours after the end of CardioPulmonary Bypass ]
    Investigators will assess the blood IL-6 concentrations between the two arms
  • Renal function [ Time Frame: daily up to day 15 ]
    Investigators will assess the blood creatinine concentrations in the two arms
  • Myoglobin concentration [ Time Frame: daily up to day 15 ]
    Investigators will assess the blood myoglobin concentrations in the two arms
  • Haptoglobin concentration [ Time Frame: daily up to day 15 ]
    Investigators will assess the blood haptoglobin concentrations in the two arms
  • 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
  • Osteopontin concentration [ Time Frame: daily up to day 15 ]
    Investigators will measure the osteopontin concentrations in the two arms to assess the inflammatory status
  • Free hemoglobin concentration [ Time Frame: daily up to day 15 ]
    Investigators will assess the free hemoglobin concentrations in the two arms
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hemadsorption During and After Cardiopulmonary Bypass to Modulate the Inflammatory Response
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Inflammatory Response
  • Chronic Renal Disease
  • Cardiac Surgery
Intervention  ICMJE
  • 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.
  • Device: Control
    No hemadsorption filter or other treatment will be included in the CPB circuit
Study Arms  ICMJE
  • Active Comparator: CytoSorb
    Patients assigned to this arm group will receive hemadsorption witbhCytoSorb during the surgery and in the next 24 hours after surgery.
    Intervention: Device: CytoSorb
  • Sham Comparator: Control
    Patients assigned to this arm group will undergo to a normal CPB without the use of any hemoadsorption system.
    Intervention: Device: Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 7, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 15, 2021
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Giuseppe F Serraino, MD 0039 0961 3647033 filiberto@live.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04157647
Other Study ID Numbers  ICMJE IMHeS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: After scientific publication
Access Criteria: On reasonable request
Responsible Party GIUSEPPE FILIBERTO SERRAINO, University Magna Graecia
Study Sponsor  ICMJE University Magna Graecia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Giuseppe Serraino, MD Magna Graecia University
PRS Account University Magna Graecia
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP