An interventional study of CytoSorb® in Cardiac Transplantation and Cardiopulmonary Bypass, sponsored by Semmelweis University. Completed at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-27.
Sponsored by Semmelweis University · Not applicable, Interventional, and Prevention
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.
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:
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.
Semmelweis University is the lead sponsor of 136 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The CytoSorb® filter will be installed into the cardiopulmonary bypass circle during cardiac transplantation in this study group (30 patients)
Device: CytoSorb®
No filter will be installed into the cardiopulmonary bypass circle in this group (30 patients).
CytoSorb® is a biocompatible, high adsorptive polymer indicated in conditions where cytokine levels are extremely elevated.
Early postoperative hemodynamic instability
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.
Time frame: 24-48 hours
Postoperative vasoplegia syndrome
Severity of postoperative vasoplegia based on criteria of vasoplegia syndrome: Norepinephrine reqirements ≥ 0.3 μg/kg/min AND arginine vasopressin requirements at any dose
Time frame: 24-48 hours
Cytokine and complement levels
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
Time frame: 24-48 hours
Inflammatory reaction
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
Time frame: 24-48 hours
Mechanical ventilation
Length of mechanical ventilation
Time frame: up to 6 months
Hospital stay
Length of ICU and hospital stay
Time frame: up to 6 months
Length of survival
Length of survival after heart transplantation
Time frame: 1 year
Medical circulatory support
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
Time frame: 72 hours
Perioperative complications
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)
Time frame: up to 1 month
The incidence of early rejection
The incidence of early (\< 1 month) cellular or humoral rejection after heart transplantation
Time frame: 1 month
Plan to share: No
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Semmelweis University