Heart Transplantation
Conditions
Keywords
Heart Transplantation, Cytosorb
Brief summary
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
Interventions
DEVICECytoSorb Adsorber
Polymer based adsorber system for the elimination of cytokines
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Prospective, single-center, single-blinded, randomized, controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients undergoing heart transplantation
Exclusion criteria
* Declined informed consent * Age \< 18 years# * Receiving antileukocyte drugs * Receiving TNF-α Blockers, immunosuppressive drugs (e.g. tocilizumab) * DCD * Ex-vivo perfusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in maximal cytokine peak levels (IL-1β, IL-6, IL-33, TNF-α, IL-10) | 5 days | Difference in maximal cytokine peak levels in various cytokine levels compared to baseline measured by ELISA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference of immunosuppression (sST2) | 30days | Individual immunosuppression measured by sST2 levels |
| primary graft dysfunction score | 7 days | Differences in primary graft dysfunction score between both groups |
| Difference of immunosuppression (TTV) | 30days | Individual immunosuppression measured by Torque-teno-virus load |
| Mechanical Ventilation | up to 4 weeks | Differences in length of mechanical ventilation |
| Delirium | 5 days | Differences in Confusion assessment method for the ICU between both groups |
| 30-day mortality | 30 days | Differences in 30-day mortality between both groups |
Countries
Austria
Contacts
Primary ContactMartin H. Bernardi, MD, PhD
Outcome results
None listed