Clearance of Antibacterial Agents During Hemoperfusion in Patients With Sepsis

Inclusion Criteria:

• Patient weight greater than 40 kg.

• Diagnosis of sepsis and/or septic shock according to CEPSIS-3 criteria (2016),presumed (at time of enrolment) to be of Gram-negative aetiology, requiring, in theopinion of the investigator, isolated lipopolysaccharide hemoperfusion.

Exclusion Criteria:

• Failure to obtain informed consent from the patient, family member or legalrepresentative.

• Any patient condition requiring other methods of renal replacement therapy (e.g.hemodialysis, hemofiltration, hemodiafiltration).

• Pregnancy, breastfeeding period.

• General contraindications to extracorporeal treatments.

• Any other condition that, in the opinion of the investigator, would prevent thepatient from being a suitable candidate for inclusion in the study (e.g. terminalchronic disease).

• Development of an adverse event, including a serious adverse event; individualintolerance to the investigational product, hypersensitivity to the components ofthe product due to which further participation in the study is not possible.

• Continued participation in the study is not, in the opinion of the investigator, inthe best interests of the patient's health.

• The patient, in the opinion of the investigator, fails to comply with therequirements of the study procedures.

• The presence of protocol deviations that, in the opinion of the Sponsor and theinvestigator, require withdrawal of the participant from the study.

• A positive pregnancy test result at any time during the study.

• Use of any other methods of renal replacement therapy and extracorporealhemocorrection during isolated hemoperfusion with the Efferon LPS device.