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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Adsorption while patients are in the OR on the extracorporeal circuit
Dept of Intensive Care Medicine
Bern, Switzerland
RECRUITINGChange 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)
Time frame: From baseline (pre-OR, t1) to day 1 post-OR (t3)
Change in mHLA-DR from baseline (pre-OR) to post-Or and 3 days post-Or.
Course of mHLA-DR
Time frame: Baseline (pre-OP) to post-OR and 3 days post-Or
Area under the curve of quantitative mHLA-DR expression
Area under the curves mHLA-DR
Time frame: Between baseline (pre-OR), post-OR, and day 1 and 3 post-OR (multiple assessments).
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
Time frame: From baseline (pre-OR) to post-OR, and day 1 and 3 post-OR
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
Time frame: 7-day timeframe (starting from ICu admission, assessed at day 90)
Length of ICU and hospital stay (days after surgical intervention).
Length of stay
Time frame: Number of days on ICU and in hospital (assessed at day 90)
Cumulative Therapeutic Intervention Scoring System (TISS) points (resource need) until ICU-discharge
Resource use
Time frame: Total number of TISS points on ICU (cumulative), assessed at day 90
Total amount of infused volume/transfusions on ICU
Need for fluid therapy
Time frame: 90 days
Duration of vasoactive drug therapy
Vasopressor use
Time frame: 90 days
Duration of invasive mechanical ventilation
Use of organ support therapy (number of days on mechanical ventilation)
Time frame: 90 days
ICU mortality rate
Number of non-surviving patients in both study groups
Time frame: ICU stay (assessed at day 90)
Hospital mortality rate
Number of non-surviving patients in both study groups
Time frame: hospital stay (assessed at day 90)
28 day mortality rate
Number of non-surviving patients in both study groups
Time frame: 28 days beginning from ICU admission (assessed at day 90)
90 day mortality rate
Number of non-surviving patients in both study groups
Time frame: 90 days beginning from ICU admission (assessed at day 90)
Duration of renal replacement therapy
Use of organ support therapy (number of days on renal replacement therapy)
Time frame: 90 days
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