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Trial record 13 of 19 for:    Cytosorb

Intraoperative Use of Extracorporeal Cytokine Adsorption During Orthotopic Heart Transplantation

This study is not yet open for participant recruitment.
Verified October 2017 by Semmelweis University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03145441
First Posted: May 9, 2017
Last Update Posted: October 6, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Semmelweis University
  Purpose

There are several factors initiating cytokine storm and systemic inflammatory response syndrome (SIRS) during cardiac transplantation. This may lead to serious perioperative complications: respiratory insufficiency, circulatory collapse, 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 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 removing cytokines during transplantation in this patient group prevents the development of extreme systemic inflammatory response syndrome, early rejection and decreases the incidence of severe perioperative complications.


Condition Intervention
Cardiac Transplantation Cardiopulmonary Bypass Device: CytoSorb®

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Semmelweis University:

Primary Outcome Measures:
  • The incidence of early rejection [ Time Frame: 1 month ]
    The incidence of early (< 1 month) cellular or humoral rejection after heart transplantation

  • 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:
  • 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

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

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

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

  • 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

  • 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)


Estimated Enrollment: 60
Anticipated Study Start Date: December 1, 2017
Estimated Study Completion Date: December 31, 2019
Estimated Primary Completion Date: March 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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 incidence of early cellular or humoral rejection, length of ventilation, ICU and hospital stay, the use of vasopressors and inotropes in the perioperative period and incidence of perioperative complications 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


Contacts
Contact: Endre Németh, ass. lect. +36208259164 nemeth.endre@med.semmelweis-univ.hu
Contact: Enikő Kovács, MD +36206632035 kovacs.eniko2@med.semmelweis-univ.hu

Sponsors and Collaborators
Semmelweis University
  More Information

Publications:
Responsible Party: Semmelweis University
ClinicalTrials.gov Identifier: NCT03145441     History of Changes
Other Study ID Numbers: SU-AITK/VM-2017/1
First Submitted: March 23, 2017
First Posted: May 9, 2017
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes