Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CytoSorb® | Experimental | The CytoSorb® filter will be installed into the cardiopulmonary bypass circle during cardiac transplantation in this study group (30 patients) |
|
| Control | No Intervention | No filter will be installed into the cardiopulmonary bypass circle in this group (30 patients). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CytoSorb® | Device | CytoSorb® is a biocompatible, high adsorptive polymer indicated in conditions where cytokine levels are extremely elevated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | 24-48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24-48 hours |
| Mechanical ventilation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University | Budapest | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27059056 | Background | Bernardi MH, Rinoesl H, Dragosits K, Ristl R, Hoffelner F, Opfermann P, Lamm C, Preissing F, Wiedemann D, Hiesmayr MJ, Spittler A. Effect of hemoadsorption during cardiopulmonary bypass surgery - a blinded, randomized, controlled pilot study using a novel adsorbent. Crit Care. 2016 Apr 9;20:96. doi: 10.1186/s13054-016-1270-0. | |
| 18090355 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Length of mechanical ventilation |
| up to 6 months |
| Hospital stay | Length of ICU and hospital stay | up to 6 months |
| Length of survival | Length of survival after heart transplantation | 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 | 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) | up to 1 month |
| The incidence of early rejection | The incidence of early (< 1 month) cellular or humoral rejection after heart transplantation | 1 month |
| Kellum JA, Venkataraman R, Powner D, Elder M, Hergenroeder G, Carter M. Feasibility study of cytokine removal by hemoadsorption in brain-dead humans. Crit Care Med. 2008 Jan;36(1):268-72. doi: 10.1097/01.CCM.0000291646.34815.BB. |
| 16606531 | Background | Liang TB, Yu ZY, Zheng SS. [Expression of non-T cell derived cytokines in acute rejection after heart transplantation: experiment with mouse model]. Zhonghua Yi Xue Za Zhi. 2006 Jan 3;86(1):26-30. Chinese. |