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To investigate whether the use of haemoadsorption (HA) on cardiopulmonary bypass during heart transplantation (HTX) has an effect on circulating cytokine levels for the first 120 hours after HTX and induces a decreased inflammatory response, increased anti-inflammatory response or immunosuppressive response. Additionally, the influence of HA on primary graft dysfunction, postoperative cerebral dysfunction, postoperative fluid accumulation, renal dysfunction, duration of mechanical ventilation, length of ICU-stay and 30-day mortality should be investigated
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adsorber Group | Active Comparator | Surgery with CPB will be performed according to institutional standards, depending on indications and surgical preferences. For the intervention group (adsorber-group), the CytoSorb adsorber will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 300-400 ml.min-1. |
|
| Control | No Intervention | The control group (no-adsorber group) will be treated similarly, but no filter circuit will be installed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CytoSorb Adsorber | Device | Polymer based adsorber system for the elimination of cytokines |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in maximal cytokine peak levels (IL-1β, IL-6, IL-33, TNF-α, IL-10) | Difference in maximal cytokine peak levels in various cytokine levels compared to baseline measured by ELISA | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of immunosuppression (TTV) | Individual immunosuppression measured by Torque-teno-virus load | 30days |
| Difference of immunosuppression (sST2) | Individual immunosuppression measured by sST2 levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin H. Bernardi, MD, PhD | Contact | 0043140400 | 41090 | martin.bernardi@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Martin H. Bernardi, MD, PhD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Divison of Cardiac Thoracic Vascular Anaesthesia and Intensive Care, Medical University of Vienna | Recruiting | Vienna | State of Vienna | 1090 | Austria |
after completion of study, the results will be published in a peer reviewed journal
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Prospective, single-center, single-blinded, randomized, controlled trial
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| 30days |
| primary graft dysfunction score | Differences in primary graft dysfunction score between both groups | 7 days |
| 30-day mortality | Differences in 30-day mortality between both groups | 30 days |
| Mechanical Ventilation | Differences in length of mechanical ventilation | up to 4 weeks |
| Delirium | Differences in Confusion assessment method for the ICU between both groups | 5 days |