Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation

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.

Conditions

• Septic Shock

Interventions

DEVICE

Efferon LPS

Blood purification with Efferon LPS

DEVICE

Toramyxin PMX 20R

Blood purification with Toramyxin PMX 20R

DEVICE

Jafron HA 330

Blood purification with Jafron HA 330

DEVICE

CytoSorb

Blood purification with Jafron HA 330

Sponsors & Collaborators

• Petrovsky National Research Centre of Surgery

  collaborator OTHER

• Bakulev Scientific Center of Cardiovascular Surgery

  collaborator OTHER_GOV

• City clinical hospital named after S. S. Yudin, Moscow City Health

  collaborator OTHER

• Sklifosovsky Institute of Emergency Care

  collaborator OTHER_GOV

• City Clinical Hospital No 52, Moscow, Russia

  collaborator UNKNOWN

• Rostov Regional Clinical Hospital

  collaborator OTHER_GOV

• Moscow Multidisciplinary Clinical Center "Kommunarka"

  lead OTHER_GOV

Principal Investigators

• Denis Protsenko, MD, PHD · Moscow Multi-disciplinary Clinical Center "Kommunarka"

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-25

Primary Completion

2027-06-25

Completion

2027-12-25

Countries

• Russia

Study Locations