About this trial
Infectious endocarditis (IE) and other severe infections are well-known to induce significant changes in the immune response including immune functionality in a considerable number of affected patients. In fact, numerous patients with IE develop a persistent functional immunological phenotype that can best be characterized by a profound anti-inflammation and/or functional anergy. This was previously referred to as "injury-associated immunosuppression (IAI)" by Pfortmüller et al., published in Intensive Care Medicine Experimental 2017. IAI can be assessed by measurement of cellular (functional) markers. Persistence of IAI is associated with prolonged ICU length of stay, increased secondary infection rates, and death. Immunomodulation to reverse IAI was shown beneficial in immunostimulatory (randomized controlled) clinical trials. CytoSorb® treatment is currently used as standard of care in some institutions in surgically treated IE patients. The investigators aim to investigate two accepted treatment protocols and aim to explore whether adsorption with a cytokine adsorption filter can increase immune competence in treated individuals.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects scheduled for routine cardiac surgery for infectious endocarditis (diagnosed according to the predefined "DUKE" criteria) with antibiotic therapy for ≤ 14 days.
Presence of informed consent
Age ≥18 yrs.
Disqualifiers
Previous treatment (last 6 months) with immunologically-active biologicals or specific immunomodulatory drugs (e.g. Rituximab)
high-dose chronic (i.e. before onset of infectious endocarditis) steroid medication with prednisone equivalent of >30 mg/d
Patients on Extracorporeal membrane oxygenation (ECMO), or any other (pre-operative) cardiac assist device
Moribund patient (life expectancy <14 days)
Trial design
Parallel
Treatments tested in this trial
Treatment protocol with adsorption
Other interventionAdsorption while patients are in the OR on the extracorporeal circuit
Treatment groups
Trial outcomes
Primary outcomes
Change in quantitative expression of monocytic Human Leukocyte Antigen (mHLA)-DR expression (Antibodies per cell on Cluster of Differentiation (CD)14+ monocytes/macrophages, assessed using a quantitative standardized assay)
Secondary outcomes
Change in mHLA-DR from baseline (pre-OR) to post-Or and 3 days post-Or.
Course of mHLA-DR
Area under the curve of quantitative mHLA-DR expression
Area under the curves mHLA-DR
Change in inflammatory markers including cytokines (Interleukin (IL)-6, IL-10, C-reactive protein, White blood cell count, multiplex Enzyme linked immunosorbent assay, and inflammatory prohormones)
Change in inflammatory parameters
Change in organ dysfunction (Sepsis-related organ failure (SOFA) scores incl. subscores and Simplified acute physiology score (SAPS II scores) daily
Course of organ dysfunction
Sponsors and contacts
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