Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation
Starting soon · Not applicable
Conditions studied: Septic Shock
In brief
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.
Key facts
- Study ID
- NCT07661303
- Run by
- Moscow Multidisciplinary Clinical Center "Kommunarka"
- People needed
- 76
- Starts
- 2026-06-25
- Expected to finish
- 2027-12-25
- Last updated by the study team
- 2026-07-02
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Septic shock according to SEPSIS-3 criteria
- Age: 18-80 years
- SOFA ≥9 points
- Diagnosis of septic shock established <12 hours ago
- Invasive hemodynamic monitoring
- Norepinephrine dose >0.2 mcg/kg/min
You may not qualify if…
- Absolute neutrophil count less than 500 cells/μL
- Pregnancy
- End-stage heart failure (NYHA stage IV)
- Pulmonary embolism with obstructive shock
- Ongoing bleeding
- Atonic coma
- More than 30 points on the MELD scale, class C on the Child-Pugh scale
- HIV infection
- Burns over 10% of the body surface area
- Patients with oncohematological diseases
- Patients with a recognized palliative status or the definition of "metastatic cancer"
- RRT using membranes with a high cutoff point and increased adsorption capacity within 72 hours from the initiation of the first hemoadsorption procedure
- Use of plasma exchange within 72 hours from the initiation of the first hemoadsorption procedure
Where it is running
- Bakulev Scientific Center of Cardiovascular Surgery — Moscow, Russia
- City clinical hospital named after S. S. Yudin, Moscow City Health — Moscow, Russia
- City Clinical Hospital No 52, Moscow, Russia — Moscow, Russia
- Moscow Multi-disciplinary Clinical Center "Kommunarka" — Moscow, Russia
- Petrovsky National Research Centre of Surgery — Moscow, Russia
- Sklifosovsky Institute of Emergency Care — Moscow, Russia
- National Medical Research Centre for Oncology Rostov-on-Don — Rostov-on-Don, Russia
Full record on ClinicalTrials.gov
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