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NCT Number: NCT03145441

Intraoperative Use of Extracorporeal Cytokine Adsorption During Orthotopic Heart Transplantation

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.

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Key information

Conditions

Cardiac Transplantation Cardiopulmonary Bypass

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Semmelweis University

Budapest, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CytoSorb®

Device

CytoSorb® is a biocompatible, high adsorptive polymer indicated in conditions where cytokine levels are extremely elevated.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

The Impact of Pre-emptive Intraoperative Use of Extracorporeal Cytokine Adsorption During Orthotopic Heart Transplantation

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 9, 2017
Registry last updated
Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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