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Recruiting NCT05711901

Selective Lipopolysaccharide Hemosorption in Maternal Sepsis

Conditions: Maternal sepsIs

Sex: Female
Ages: 18 Years – N/A
Phase: NA
Enrollment: 80
Sponsor: Efferon JSC

Location: Russian Federation

Summary

One of the major health problems in the world is sepsis, the number of cases of which, according to WHO, annually reaches 20-30 million.The prevalence and frequency of obstetric sepsis are quite pronounced. Thus, in Europe, up to 500,000 cases of sepsis are registered annually. In Russia, the frequency of obstetric purulent-inflammatory diseases in the structure of maternal mortality ranges from 5 to 26%, according to some data - up to 45-75%. In the structure of maternal mortality, this pathology is in second or third place. Numerous studies have shown that the use of extracorporeal sorption methods that eliminate endotoxin and cytokines improves the results of treatment of patients with septic shock. The main goal of the study was to obtain new data on the efficacy and safety of using the Efferon LPS device for hemosorption of lipopolysaccharides during extracorporeal detoxification in patients with obstetric sepsis.

Eligibility Criteria

Inclusion Criteria:Age ≥18 yearsAn 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 embolismTransfusion 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).

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Source: ClinicalTrials.gov (NCT05711901). StuddyBuddy aggregates publicly available trial information.