Intraoperative Use of Extracorporeal Cytokine Adsorption During Orthotopic Heart Transplantation

Semmelweis University

Status: Completed

Conditions: Cardiac Transplantation; Cardiopulmonary Bypass

Treatments: Device: CytoSorb®

Study type: Interventional

Funder types: Other

Identifiers

NCT03145441

SU-AITK/VM-2017/1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

CytoSorb®

Experimental group

Description:

The CytoSorb® filter will be installed into the cardiopulmonary bypass circle during cardiac transplantation in this study group (30 patients)

Treatment:

Device: CytoSorb®

Control

No Intervention group

Description:

No filter will be installed into the cardiopulmonary bypass circle in this group (30 patients).