Clinical Research Directory

Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation

Sponsor: Moscow Multidisciplinary Clinical Center "Kommunarka"

Summary

Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation. A Pilot Multicenter Randomized Controlled Trial. The goal of this clinical trial is the estimation of the efficacy and safety of hemoadsorption procedures (LPS (Lipopolysaccharide) and inflammatory mediators adsorption) in participants with septic shock. The main questions it aims to answer are: Does hemoadsorption decrease the severity of MODS (multiple organ disfunction syndrome)? The study will include participants aged 18 to 80 years with a verified diagnosis of septic shock according to SEPSIS 3 criteria, diagnosed within 12 hours, and a SOFA (sequential organ failure assessment) score of 9 or more. In addition to Standard of Care (SOC), blood purification, including hemoadsorption, will be used. The minimum waiting time after diagnosis of septic shock and initiation of basic therapy before inclusion of the patient in the study therapy is 4 hours. The choice of procedure will be based on the EAA (Endotoxin Activity Assay) result: * for an EAA level of 0.6-0.9, selective lipopolysaccharide (LPS) adsorption with duration from 2 to 10 hours; * for an EAA level less than 0.6, inflammatory mediator adsorption with duration from 6 to 12 hours. The choice of a specific adsorbers within the LPS and inflammatory mediator adsorption group will be based on randomization. The use of LPS adsorption is planned based on randomization: Toramyxin R-20 or Efferon LPS. The use of inflammatory mediator adsorption is planned based on randomization: Jafron (HA 330) or CytoSorb.

Official title: Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation. A Pilot Multicenter Randomized Controlled Trial

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