Intraoperative Use of Extracorporeal Cytokine Adsorption During Orthotopic Heart Transplantation
- Conditions
- Cardiopulmonary BypassCardiac Transplantation
- Interventions
- Device: CytoSorb®
- Registration Number
- NCT03145441
- Lead Sponsor
- Semmelweis University
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- patients undergoing heart transplantation
- no medical or mechanical circulatory support straight before transplantation
- age > 18 years
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CytoSorb® CytoSorb® The CytoSorb® filter will be installed into the cardiopulmonary bypass circle during cardiac transplantation in this study group (30 patients)
- Primary Outcome Measures
Name Time Method Early postoperative hemodynamic instability 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.Postoperative vasoplegia syndrome 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
Cytokine and complement levels 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
Name Time Method Mechanical ventilation up to 6 months Length of mechanical ventilation
Hospital stay up to 6 months Length of ICU and hospital stay
Length of survival 1 year Length of survival after heart transplantation
Inflammatory reaction 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
Medical circulatory support 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
The incidence of early rejection 1 month The incidence of early (\< 1 month) cellular or humoral rejection after heart transplantation
Perioperative complications 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)
Trial Locations
- Locations (1)
Semmelweis University
🇭🇺Budapest, Hungary