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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
288
Use of the hemoadsorber during cardiac surgery with CPB. Hemoadsorber is integrated into the CPB circuit according to manufacturer's recommendation.
University Heart Center Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, Germany
University Heart Center Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
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
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University Hospital Ulm, Clinics of Heart-, Thoracic and Cardiovascular Surgery
Ulm, Baden-Wurttemberg, Germany
University Hospital Cologne, Clinic and Policlinics for Heart and Thoracic Surgery
Cologne, North Rhine-Westphalia, Germany
University Hospital Essen, Clinic of Thoracic and Cardiovascular Surgery
Essen, North Rhine-Westphalia, Germany
Jena University Hospital, Dept. of Cardiac and Thoracic Surgery
Jena, Thuringia, Germany
Herz- und Diabeteszentrum NRW, Klinik für Thorax- und Kardiovaskularchirurgie
Bad Oeynhausen, Germany
Herzzentrum Brandenburg, Immanuel Klinikum Bernau
Bernau bei Berlin, Germany
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH, Klinik für Herz- und Thoraxchirurgie
Bochum, Germany
Universitätsklinikum Bonn, Klinik und Poliklinik für Herzchirurgie
Bonn, Germany
...and 4 more locations