Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation
HAdSS
1 other identifier
interventional
76
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2026
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2026
CompletedFirst Posted
Study publicly available on registry
June 22, 2026
CompletedStudy Start
First participant enrolled
June 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 25, 2027
July 2, 2026
June 1, 2026
1 year
June 16, 2026
June 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SOFA (sequential organ failure assessment) score
MODS (multiple organ disfunction syndrome) dynamics majored by SOFA (sequential organ failure assessment) score. SOFA score ranges from 0 (best) to 24 (worst) points.
Assessed at 72 hours after hemoadsorption initiation
Secondary Outcomes (20)
Vasoactive Inotropic Score (VIS) dynamics
Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
Norepinephrine dose dynamics
Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
Hemodynamic index dynamics
Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
Horowitz index dynamics
Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
Lactate level dynamics
Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
- +15 more secondary outcomes
Other Outcomes (6)
Ventilator-free days
Will be calculated for 28 days after hemoadsorption initiation
Vasopressor-free days
Will be calculated for 28 days after hemoadsorption initiation
Dialysis-free days
Will be calculated for 28 days after hemoadsorption initiation
- +3 more other outcomes
Study Arms (4)
Inflammatory mediatiors adsorption with CytoSorb
EXPERIMENTALInflammatory mediatiors adsorption with EAA \<0,6 with CytoSorb
Inflammatory mediatiors adsorption with Jafron HA 330
ACTIVE COMPARATORInflammatory mediatiors adsorption with EAA \<0,6 with Jafron HA 330
Endotoxin haemoadsorption with Toramyxin PMX 20R
EXPERIMENTALEndotoxin haemoadsorption with EAA \[0.6-0.9\] with Toramyxin PMX 20R
Endotoxin haemoadsorption with Efferon LPS
ACTIVE COMPARATOREndotoxin haemoadsorption with EAA \[0.6-0.9\] with Efferon LPS
Interventions
Blood purification with Toramyxin PMX 20R
Blood purification with Jafron HA 330
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Moscow Multidisciplinary Clinical Center "Kommunarka"lead
- Petrovsky National Research Centre of Surgerycollaborator
- Bakulev Scientific Center of Cardiovascular Surgerycollaborator
- City clinical hospital named after S. S. Yudin, Moscow City Healthcollaborator
- Sklifosovsky Institute of Emergency Carecollaborator
- City Clinical Hospital No 52, Moscow, Russiacollaborator
- Rostov Regional Clinical Hospitalcollaborator
Study Sites (7)
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
Related Publications (5)
Onuk S, Akin AK, Sari A, Gundogan K, Baskol G, Dogru K, Sungur M. The Clinical and Laboratory Efficacy of HA 330 Treatment Combined with Continuous Renal Replacement Therapy in Septic Shock Patients: A Case Series. Blood Purif. 2023;52(2):140-147. doi: 10.1159/000528150. Epub 2023 Jan 12.
PMID: 36634624BACKGROUNDMehta Y, Mehta C, Kumar A, George JV, Gupta A, Nanda S, Kochhar G, Raizada A. Experience with hemoadsorption (CytoSorb(R)) in the management of septic shock patients. World J Crit Care Med. 2020 Jan 31;9(1):1-12. doi: 10.5492/wjccm.v9.i1.1. eCollection 2020 Jan 31.
PMID: 32104647BACKGROUNDRey S, Kulabukhov VM, Popov A, Nikitina O, Berdnikov G, Magomedov M, Kim T, Masolitin S, Ignatenko O, Krotenko N, Marysheva A, Chaus N, Ohinko L, Mendibaev M, Chumachenko A, Pisarev V. HEMOPERFUSION USING THE LPS-SELECTIVE MESOPOROUS POLYMERIC ADSORBENT IN SEPTIC SHOCK: A MULTICENTER RANDOMIZED CLINICAL TRIAL. Shock. 2023 Jun 1;59(6):846-854. doi: 10.1097/SHK.0000000000002121. Epub 2023 Apr 6.
PMID: 37018802BACKGROUNDCruz DN, Antonelli M, Fumagalli R, Foltran F, Brienza N, Donati A, Malcangi V, Petrini F, Volta G, Bobbio Pallavicini FM, Rottoli F, Giunta F, Ronco C. Early use of polymyxin B hemoperfusion in abdominal septic shock: the EUPHAS randomized controlled trial. JAMA. 2009 Jun 17;301(23):2445-52. doi: 10.1001/jama.2009.856.
PMID: 19531784BACKGROUNDKlein DJ, Foster D, Walker PM, Bagshaw SM, Mekonnen H, Antonelli M. Polymyxin B hemoperfusion in endotoxemic septic shock patients without extreme endotoxemia: a post hoc analysis of the EUPHRATES trial. Intensive Care Med. 2018 Dec;44(12):2205-2212. doi: 10.1007/s00134-018-5463-7. Epub 2018 Nov 23.
PMID: 30470853BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Denis Protsenko, MD, PHD
Moscow Multi-disciplinary Clinical Center "Kommunarka"
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double (Investigator, Outcomes Assessor)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2026
First Posted
June 22, 2026
Study Start
June 25, 2026
Primary Completion (Estimated)
June 25, 2027
Study Completion (Estimated)
December 25, 2027
Last Updated
July 2, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data will become available immediately following the official publication of the primary trial results, approximately at 12/2027.
- Access Criteria
- The dataset will be openly accessible to any researcher, clinician, or analyst interested in replicating the study findings, conducting systematic reviews, or performing secondary meta-analyses. The data will be hosted publicly, and no formal research proposal review or data use agreements are required for access.
De-identified individual participant data (IPD) that underlie the results reported in the primary publication (including baseline characteristics, blood purification parameters, hemodynamics and SOFA score dynamics, clinical outcomes) will be made publicly available to ensure absolute transparency and academic reproducibility.