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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03145441
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Semmelweis University

Tracking Information
First Submitted Date  ICMJE March 23, 2017
First Posted Date  ICMJE May 9, 2017
Last Update Posted Date April 8, 2019
Actual Study Start Date  ICMJE April 9, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2017)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2017)
  • 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 (CBP), 2 hours after initiation of CBP, at termination of CBP, 6-12-24 hours after initiation of CBP
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2017)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2017)
  • 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 (CBP), 2 hours after initiation of CBP, at termination of CBP, 6-12-24 hours after initiation of CBP
  • 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 (CBP), 2 hours after initiation of CBP, at termination of CBP, 6-12-24 hours after initiation of CBP, 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intraoperative Use of Extracorporeal Cytokine Adsorption During Orthotopic Heart Transplantation
Official Title  ICMJE The Impact of Pre-emptive Intraoperative Use of Extracorporeal Cytokine Adsorption During Orthotopic Heart Transplantation
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiac Transplantation
  • Cardiopulmonary Bypass
Intervention  ICMJE Device: CytoSorb®
CytoSorb® is a biocompatible, high adsorptive polymer indicated in conditions where cytokine levels are extremely elevated.
Study Arms  ICMJE
  • Experimental: CytoSorb®
    The CytoSorb® filter will be installed into the cardiopulmonary bypass circle during cardiac transplantation in this study group (30 patients)
    Intervention: Device: CytoSorb®
  • No Intervention: Control
    No filter will be installed into the cardiopulmonary bypass circle in this group (30 patients).
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 4, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Endre Németh, ass. lect. +36208259164 nemeth.endre@med.semmelweis-univ.hu
Contact: Enikő Kovács, MD +36206632035 kovacs.eniko2@med.semmelweis-univ.hu
Listed Location Countries  ICMJE Hungary
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03145441
Other Study ID Numbers  ICMJE SU-AITK/VM-2017/1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Semmelweis University
Study Sponsor  ICMJE Semmelweis University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Semmelweis University
Verification Date April 2019

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