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Intraoperative Use of Extracorporeal Cytokine Adsorption During Orthotopic Heart Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03145441
Recruitment Status : Completed
First Posted : May 9, 2017
Last Update Posted : September 27, 2022
Sponsor:
Information provided by (Responsible Party):
Semmelweis University

Study Description
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Brief Summary:

There are several factors initiating cytokine storm and dysregulated systemic inflammatory response during cardiac transplantation. This may lead to serious perioperative complications: circulatory collapse, respiratory insufficiency, acute renal and liver failure, multi-organ dysfunction etc.

On the other hand the high level of cytokines may play an important role in the development of graft rejection which is still a relevant problem in this patient group.

There are some new data showing that the use of extracorporeal cytokine adsorber during long cardiopulmonary bypass time (>120min) may be beneficial to prevent SIRS (Systemic Inflammatory Response Syndrome) with decreasing the level of cytokines in patients undergoing elective cardiac surgery. However there is lack of data and studies regarding the effect of extracorporeal cytokine adsorption during cardiac transplantation.

The aim of the study is to investigate the effect of extracorporeal cytokine adsorber built in the cardiopulmonary bypass circle during heart transplantation. The hypothesis is that removal of cytokines during heart transplantation prevents the development of extreme systemic inflammatory response, hemodynamic collapse dominated by vasoplegia, and contribute to reduce the incidence of severe perioperative complications and early graft rejection.


Condition or disease Intervention/treatment Phase
Cardiac Transplantation Cardiopulmonary Bypass Device: CytoSorb® Not Applicable

Detailed Description:

Patients undergoing cardiac transplantation will be enrolled in the study after giving a written, signed informed consent.

The participants will be randomized into two groups:

  • intervention group (30 patients): a cytokine adsorber (CytoSorb®) will be installed into the cardiopulmonary bypass circle during the operation
  • control group (30 patients): no cytokine adsorber will be used during cardiopulmonary bypass

The investigators will collect demographic, clinical and laboratory data about patients before, during and after the operation.

The the use of vasopressors and inotropes in the perioperative period, length of mechanical ventilation, ICU and hospital stay, and incidence of perioperative complications, early cellular or humoral graft rejection, and survival will be documented.

The level of cytokines (IL-1, IL-6, IL-10, IL-17, tumor necrosis factor-alfa) and complements before, during and after the use of cardiopulmonary bypass will be determined if the investigators find relevant difference between the two groups in clinical variables.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Impact of Pre-emptive Intraoperative Use of Extracorporeal Cytokine Adsorption During Orthotopic Heart Transplantation
Actual Study Start Date : April 9, 2018
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CytoSorb®
The CytoSorb® filter will be installed into the cardiopulmonary bypass circle during cardiac transplantation in this study group (30 patients)
 Device: CytoSorb®
CytoSorb® is a biocompatible, high adsorptive polymer indicated in conditions where cytokine levels are extremely elevated.
No Intervention: Control
No filter will be installed into the cardiopulmonary bypass circle in this group (30 patients).


Outcome Measures
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Primary Outcome Measures :
  1. Early postoperative hemodynamic instability [ Time Frame: 24-48 hours ]

    Hemodynamic instability described by Vasoactive Inotropic Score and calculated for the first two postoperative days.

    Vasoactive Inotropic Score is considered as 'high' if values ≥ 30 points, representing higher risk for worse outcomes.


  2. Postoperative vasoplegia syndrome [ Time Frame: 24-48 hours ]
    Severity of postoperative vasoplegia based on criteria of vasoplegia syndrome: Norepinephrine reqirements ≥ 0.3 μg/kg/min AND arginine vasopressin requirements at any dose

  3. Cytokine and complement levels [ Time Frame: 24-48 hours ]
    Level of pro- and anti-inflammatory cytokines (IL-1, IL-6, IL-10, IL-17, tumor necrosis factor-alfa) and complements immediately after induction of anesthesia, before initiation of cardiopulmonary bypass (CPB), 2 hours after initiation of CPB, at termination of CPB, 6-12-24 hours after initiation of CPB


Secondary Outcome Measures :
  1. Inflammatory reaction [ Time Frame: 24-48 hours ]
    Level of C reactive protein (CRP), white blood cells and procalcitonin immediately after induction of anesthesia, before initiation of cardiopulmonary bypass (CPB), 2 hours after initiation of CPB, at termination of CPB, 6-12-24 hours after initiation of CPB

  2. Mechanical ventilation [ Time Frame: up to 6 months ]
    Length of mechanical ventilation

  3. Hospital stay [ Time Frame: up to 6 months ]
    Length of ICU and hospital stay

  4. Length of survival [ Time Frame: 1 year ]
    Length of survival after heart transplantation

  5. Medical circulatory support [ Time Frame: 72 hours ]
    Use and dosage of vasopressors and inotropes immediately after induction of anesthesia, before initiation of cardiopulmonary bypass (CPB), 2 hours after initiation of CPB, at termination of CPB, 6-12-24 hours after initiation of CPB, on 2nd and 3rd postoperative day

  6. Perioperative complications [ Time Frame: up to 1 month ]
    Incidence of perioperative complications after heart transplantation during ICU stay (sepsis, SIRS, respiratory failure, acute renal failure, acute liver failure, postoperative cognitive dysfunction, graft failure)

  7. The incidence of early rejection [ Time Frame: 1 month ]
    The incidence of early (< 1 month) cellular or humoral rejection after heart transplantation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing heart transplantation
  • no medical or mechanical circulatory support straight before transplantation
  • age > 18 years

Exclusion Criteria:

  • age < 18 years
  • septic condition (controlled infection) before transplantation
  • prolonged hospital stay straight before transplantation
  • use of positive inotropes or vasopressors straight before transplantation
  • use of mechanical circulatory support straight before transplantation
  • acute liver or kidney failure straight before transplantation
  • high urgency transplantation
  • retransplantation
  • the patient declines participating in the study
Contacts and Locations
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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): NCT03145441


Locations
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Hungary
Semmelweis University
Budapest, Hungary
Sponsors and Collaborators
Semmelweis University
More Information
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Publications:

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Responsible Party: Semmelweis University
ClinicalTrials.gov Identifier: NCT03145441    
Other Study ID Numbers: SU-AITK/VM-2017/1
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: September 27, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes