Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation (NCT07661303) | Clinical Trial Compass
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Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation
Russia76 participantsStarted 2026-06-25
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
SOFA (sequential organ failure assessment) score
Timeframe: Assessed at 72 hours after hemoadsorption initiation
Trial details
NCT IDNCT07661303
SponsorMoscow Multidisciplinary Clinical Center "Kommunarka"