Heart Transplantation Clinical Trial
— CytoSorbHTXOfficial title:
Effect of Haemoadsorption During Cardiopulmonary Bypass on Patients After Heart Transplantation
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
Status | Recruiting |
Enrollment | 40 |
Est. completion date | June 30, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patients undergoing heart transplantation Exclusion Criteria: - Declined informed consent - Age < 18 years# - Receiving antileukocyte drugs - Receiving TNF-a Blockers, immunosuppressive drugs (e.g. tocilizumab) - DCD - Ex-vivo perfusion |
Country | Name | City | State |
---|---|---|---|
Austria | Divison of Cardiac Thoracic Vascular Anaesthesia and Intensive Care, Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in maximal cytokine peak levels (IL-1ß, IL-6, IL-33, TNF-a, IL-10) | Difference in maximal cytokine peak levels in various cytokine levels compared to baseline measured by ELISA | 5 days | |
Secondary | Difference of immunosuppression (TTV) | Individual immunosuppression measured by Torque-teno-virus load | 30days | |
Secondary | Difference of immunosuppression (sST2) | Individual immunosuppression measured by sST2 levels | 30days | |
Secondary | primary graft dysfunction score | Differences in primary graft dysfunction score between both groups | 7 days | |
Secondary | 30-day mortality | Differences in 30-day mortality between both groups | 30 days | |
Secondary | Mechanical Ventilation | Differences in length of mechanical ventilation | up to 4 weeks | |
Secondary | Delirium | Differences in Confusion assessment method for the ICU between both groups | 5 days |
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