Lipopolysaccharide Adsorption At Septic Shock (LASSO)

Efferon

Status: Completed

Conditions: Septic Shock

Treatments: Device: Efferon LPS hemoperfusion

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT04827407

efferon-lps-2021-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years

• Established diagnosis of Gram-negative septic shock according to SEPSIS-3 criteria

• The immediate post-operative period (no more than 24 hours after surgery)

• Hypotension requiring vasopressor support: the need for at least one of the vasopressors listed below at the dose listed below for at least 2 hours continuously and not more than 12 hours.

  • Norepinephrine> 0.05 µg/kg/min
  • Dopamine> 10 µg/kg/min
  • Phenylephrine> 0.4 µg/kg/min
  • Adrenaline > 0.05 µg/kg/min
  • Vasopressin> 0.03 units/min Vasopressin (any dose) in combination with another vasopressor listed above

• The patient must have received intravenous infusion therapy of at least 30 ml/kg administered within 24 hours of inclusion.

• The patient's condition allows therapy with the Efferon LPS device for at least 4 hours.

Exclusion criteria

Lack of adequate antimicrobial chemotherapy

• Identifying the criteria for non-inclusion;
• A patient may voluntarily withdraw from a trial at any time after giving informed consent and before the trial is completed. The investigator may also withdraw a participant from the trial at any time at his or her discretion and for any of the following reasons:
• Reasons for a participant's withdrawal from the trial will be recorded and may include, amongst others, the following
• Withdrawal of consent to participate in the trial by the participant.
• The development of an adverse event, including a serious one; individual intolerance to the investigational product, hypersensitivity to the components of the product due to which further participation in the trial is not possible.
• Continued participation in the trial is not, in the researcher's opinion, in the participant's health interests.
• The presence of deviations from the plan which, in the opinion of the Sponsor and Investigator, require the withdrawal of the participant from the trial.
• A positive pregnancy test result at any time during the test.
• When any participant withdraws from a trial, the reason for the withdrawal should be documented.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Basic therapy + Efferon LPS

Experimental group

Description:

Basic therapy is the institution's routine practice for treating patients with septic shock against a background of abdominal sepsis plus extracorporeal hemoperfusion therapy (Efferon LPS)

Treatment:

Device: Efferon LPS hemoperfusion

Baseline therapy

No Intervention group

Description:

Basic therapy is the institution's routine practice for treating patients with septic shock against a background of abdominal sepsis.