An interventional study of hemoadsorber for removal of cytokines in Infective Endocarditis, sponsored by Jena University Hospital. Completed at 14 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-18.
Sponsored by Jena University Hospital · Not applicable, Interventional, and Prevention
Infective endocarditis (IE) is associated with high hospital mortality for various reasons; one of them is circulatory failure in patients who undergo cardiac surgery for IE. One discussed reason underlying circulatory failure during surgery is the release of vasodilatatory mediators and cytokines. This study examines the efficacy and safety of a hemoadsorption filter which is approved for the reduction of the concentration of cytokines in the bloodstream.
The investigators assume a common standard deviation of 3.8 points and that a 1.4-point lower SOFA score in the Intervention Group is of clinical relevance.
Exclusion Criteria:
Use of hemoadsorber for removal of cytokines. Participants undergoing cardiac surgery due to infective endocarditis will be treated using a hemoadsorption device (CytoSorb) within the cardiopulmonary Bypass circuit (=Intervention)
Device: hemoadsorber for removal of cytokines
Participants undergoing cardiac surgery due to infective endocarditis will be treated according to Standard of care (no hemoadsorption advice installed in the CPB circuit)
Use of the hemoadsorber during cardiac surgery with CPB. Hemoadsorber is integrated into the CPB circuit according to manufacturer's recommendation.
Also known as: CytoSorb(R)
SOFA Score
The investigators will test if mean SOFA scores are different for the experimental and control group.
Time frame: 24 hours before until day 9 post-surgery
Overall mortality rate
Overall mortality rate until day 30 post-surgery
Time frame: until day 30 post surgery
Changes in cytokine and cfDNA levels
changes in cytokine and cfDNA levels will be measured at different time points before, during and after surgery in both groups; only for the first 2x25 patients
Time frame: 24 hours before, during cardiac surgery and 24 hours after surgery
SOFA subscores
single SOFA subscores will be analyzed
Time frame: 24 hours before surgery until day 9 post-surgery
Days on ventilator, vasopressor and renal replacement therapy
Total days on ventilator, vasopressor and renal replacement therapy within 30 days post-surgery will be assessed
Time frame: until day 30 post-surgery
incidence of stroke
incidence of stroke within 30 days post-surgery will be assessed
Time frame: until day 30 post-surgery
length of ICU and in-hospital stay
total length of ICU and in-hospital stay until day 30 post-surgery
Time frame: until day 30 post-surgery
Plan to share: No
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Jena University Hospital