Lipopolisaccharide Adsorption at Septic Shock
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Study type: Interventional

Summary: 
      Sepsis is a global healthcare burden sepsis, it reaches 20-30 million cases annually (WHO
      data). Numerous studies have shown that extracorporeal hemoperfusion therapies that eliminate
      endotoxin and\or excess of cytokines improve treatment outcomes in patients with septic
      shock. The main purpose of the study is to obtain new data on the efficacy and safety of the
      Efferon LPS device in extracorporeal therapy in patients with abdominal sepsis complicated by
      septic shock.
    

Detailed description: 
      Sepsis is a global healthcare burden sepsis, it reaches 20-30 million cases annually (WHO
      data). A two-stage trial by Rudnov et al. using one-day data from 62 centres in 29 subjects
      of the Russian Federation showed that one third of the patients admitted to the ICU were
      patients with infection, one fifth of them developed septic shock, the proportion of hospital
      sepsis was 46.6%, and fatal outcome occurred in 30.4% of patients with infection. Despite
      apparent advances in intensive care, the prognosis of patients with endotoxaemia and septic
      shock remains poor.

      Extracorporeal removal of toxic substances from the bloodstream by adsorbing them onto a
      porous material may provide clear clinical benefits. Extracorporeal blood adsorption method
      can be a good complement or substitute for the classical methods of haemofiltration and
      haemodialysis if the diffusion or convection of toxic substances through the membrane is not
      efficient enough. Since the method was first proposed by Muirhead and Reid in 1948, it has
      developed considerably.

      Endotoxin (lipopolysaccharide), one of the most potent mediators of sepsis, is found in high
      concentrations in about 50% of patients with septic shock. The use of extracorporeal sorption
      techniques that eliminate endotoxin has been shown in numerous trials to improve outcomes in
      patients with septic shock.

      Efferon LPS (Efferon JSC, Moscow, Russia) is a single-use therapeutic device for
      extracorporeal blood purification using direct hemoperfusion. Detoxification is carried out
      by selective adsorption of lipopolysaccharides (bacterial endotoxins) and non-selective
      removal of cytokines by internal porous structure. It is a cylindrical polycarbonate casing
      filled with spherical granules of LPS-selective polymeric adsorbent mesoporous beads and
      isotonic sodium chloride solution. The device is registered in Russia as a medical device RZN
      2019/8886.
    

Intervention name(s): Efferon LPS hemoperfusion
Intervention type(s): Device
Intervention description(s): Hemoperfusion using continuous extracorporeal LPS adsorption with Efferon LPS therapeutic device during a period of 24h immediately following admission to the intensive care unit
Other intervention name(s): extracorporeal blood adsorption
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A multicentre randomised clinical trial evaluating the efficacy and safety of the Efferon LPS device in extracorporeal hemoperfusion in patients with abdominal sepsis complicated with septic shock.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: septic shock; extracorporeal therapy; LPS adsorption; abdominal sepsis