Selective Lipopolysaccharide Hemosorption in Maternal Sepsis (MINERVA)
Maternal sepsIs
About this trial
This is an interventional treatment trial for Maternal sepsIs focused on measuring septic shock, maternal sepsIs, lipopolysaccharide sorption, obstetric sepsis
Eligibility Criteria
Inclusion Criteria: Age ≥18 years An established diagnosis of sepsis according to the criteria for SEPSIS-3, most likely Gram-negative etiology, at the time of inclusion. No more than 12 hours from the time of setting DS - Sepsis and/or Septic Shock. In case of septic shock: • Hypotension requiring vasopressor support for at least 2 hours continuously and no more than 12 hours. In the absence of Septic shock, but in the presence of suspicion of sepsis (before the detection of flora) and organ dysfunction, inclusion in the clinical trial is based on 2 of the 4 SIRS criteria, • SOFA ≥ 4 points. Exclusion Criteria: Inability to obtain informed consent from the patient, family member or legal representative, The presence of a focus of non-sanitized surgical infection, The use of other methods of extracorporeal removal of LPS and inflammatory mediators in the treatment of septic shock (hemofilters with highly permeable and surface-modified membranes) In Septic Shock, failure to achieve or maintain a minimum mean arterial pressure (MAP) ≥ 65 mmHg. Art., despite vasopressor therapy and infusion therapy for 24 hours, End-stage renal disease and need for chronic dialysis. Acute pulmonary embolism Transfusion reaction, Severe congestive heart failure, Uncontrolled bleeding (acute blood loss in the last 24 hours), Severe granulocytopenia (white blood cell count less than 500 cells/mm3), Any other condition that, in the opinion of the investigator, would prevent the patient from being a suitable candidate for inclusion in the study (eg terminal chronic disease).
Sites / Locations
- National Medical Research Center For Obstetrics, Gynecology and Perinatology Named After Academician V.I.KulakovRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
No Intervention: Baseline therapy
Experimental: Basic therapy + Efferon LPS
Basic therapy - the routine practice of an institution for the treatment of patients with maternal sepsis
Basic therapy is a routine practice of the institution for the treatment of patients with maternal sepsis plus extracorporeal hemoperfusion therapy (Efferon LPS)