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Septic ShockHAdSSNCT07661303

Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation

A study testing Efferon LPS, Toramyxin PMX 20R and Jafron HA 330 in people with Septic Shock, run by Moscow Multidisciplinary Clinical Center "Kommunarka" at 7 sites in Russia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Septic Shock
What is being tested?
Efferon LPS, Toramyxin PMX 20R and Jafron HA 330
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
7 sitesRussia
Study dates
25 Jun 2026to 25 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Aleksandr Burov, PHD contact

+79854215478

Aleksander.bour@mail.ru

7 sites in 1 country

Russia7 sites

  • Bakulev Scientific Center of Cardiovascular Surgery

    Moscow

    Mikhail Yarustovskiy, MD, PHD, +79104194682, mbyar@yandex.ru

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

    Moscow

    Nikolay Krotenko, PHD, +79268664976, npkrotenko@gmail.com

  • City Clinical Hospital No 52, Moscow, Russia

    Moscow

    Rustam Iskhakov, +79265317813, stamius@yandex.ru

  • Moscow Multi-disciplinary Clinical Center "Kommunarka"

    Moscow

  • Petrovsky National Research Centre of Surgery

    Moscow

    Maxim Babaev, MD, PHD, +79160269066, maxbabaev@mail.ru

  • Sklifosovsky Institute of Emergency Care

    Moscow

    Sergei Rei, PHD, +79166001362, reysi@sklif.mos.ru

  • National Medical Research Centre for Oncology Rostov-on-Don

    Rostov-on-Don

    Natalia Ushakova, MD, PHD, +79185533155, ndu2000@rambler.ru

Other trials in Russia

About this study

Official title: Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation. A Pilot Multicenter Randomized Controlled Trial

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.

Read more

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.

Read the detailed description

Every participant will receive 2 adsorption procedures. The second procedure will be initiated no later than 24 hours after the initiation of the first procedure.

LPS adsorption will be performed in 38 participants (Efferon LPS in 19 participants and Toramyxin in 19 participants), two procedures per participant.

Inflammatory mediator adsorption will be performed in 38 participants (Jafron HA 330 in 19 participants and CytoSorb in 19 participants), two procedures per participant.

Sample size calculations were performed separately for each treatment cohort. For the endotoxemia cohort (EAA level of 0.6-0.9), this randomized trial is designed to compare Efferron LPS and Toraymyxin with respect to change in SOFA score at 72 hours.

At present, no universally accepted minimal clinically important difference (MCID) has been established for the SOFA score in participants with septic shock. Therefore, the assumed treatment effect was derived from published evidence and expert clinical judgment.

In the EUPHAS trial, polymyxin B hemoperfusion was associated with a mean reduction in SOFA score of approximately 3.4 points at 72 hours, whereas minimal change was observed in the control group. Similarly, the LASSO study demonstrated substantial improvement in organ dysfunction following endotoxin adsorption therapy.

For the inflammatory mediator adsorption cohort (EAA level less than 0.6), this randomized trial is designed to compare CytoSorb and Jafron HA 330 with respect to change in SOFA score at 72 hours.

In the retrospective study Mehta et al., CytoSorb hemoperfusion was associated with a mean reduction in SOFA score of approximately 2.0 points after treatment in survival group. Similarly, the case series Onuk et al. demonstrated substantial improvement in organ dysfunction following inflammatory adsorption therapy with Jafron HA 330 with a mean reduction in SOFA score of approximately 3.5 points at 72 hours.

A between-group difference of 2.5 SOFA points was considered clinically meaningful for both Endotoxin hemoadsorption and inflammatory mediators hemoadsorption because it represents a substantial proportion of the treatment effect observed in previous hemoperfusion studies and corresponds to a clinically relevant difference in the degree of organ dysfunction improvement.

The sample size for both groups (LPS and inflammatory mediator adsorption) was calculated based on the following assumption: the primary endpoint was the change in SOFA score at 72 hours (ΔSOFA); the expected between-group difference - 2.5 points on the SOFA score; standard deviation of ΔSOFA - 2.5 points; equal allocation ratio (1:1); two-sided significance level (α) of 0.05; statistical power of 80%.

Sample size estimation was performed in R using the power.t.test() function. The calculation yielded a required sample size of 16.7 participants per group. Therefore, a minimum of 17 participants per group (34 participants in total) is required to achieve the planned statistical power.

To account for an anticipated 10% dropout rate, the final sample size will be 19 patients per group (38 participants in total for LPS+ 38 participants in total for Inflammatory mediators adsorption. 76 participants in total).

Conditions
Septic Shock
Being tested
Efferon LPS, Toramyxin PMX 20R, Jafron HA 330, CytoSorb
Keywords
Septic shock, hemoadsorption, blood purification, MODS, Endotoxemia
Medical subject headings
Shock, Septic, Multiple Organ Failure, Endotoxemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Efferon LPSDevice

    Blood purification with Efferon LPS

  • Toramyxin PMX 20RDevice

    Blood purification with Toramyxin PMX 20R

  • Jafron HA 330Device

    Blood purification with Jafron HA 330

  • CytoSorbDevice

    Blood purification with Jafron HA 330

Study groups in NCT07661303
Study groupRoleWhat they receive
Inflammatory mediatiors adsorption with CytoSorbExperimentalInflammatory mediatiors adsorption with EAA <0,6 with CytoSorb
Receives: Device: CytoSorb
Inflammatory mediatiors adsorption with Jafron HA 330Active comparatorInflammatory mediatiors adsorption with EAA <0,6 with Jafron HA 330
Receives: Device: Jafron HA 330
Endotoxin haemoadsorption with Toramyxin PMX 20RExperimentalEndotoxin haemoadsorption with EAA [0.6-0.9] with Toramyxin PMX 20R
Receives: Device: Toramyxin PMX 20R
Endotoxin haemoadsorption with Efferon LPSActive comparatorEndotoxin haemoadsorption with EAA [0.6-0.9] with Efferon LPS
Receives: Device: Efferon LPS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Assessed at 72 hours after hemoadsorption initiation

Secondary outcomes (20)

  1. Vasoactive Inotropic Score (VIS) dynamics

    Vasoactive Inotropic Score (VIS) dynamics

    VIS = dopamine dose (mcg∕kg∕ min ) + dobutamine dose (mcg∕kg∕ min ) + 100 × epinephrine dose (mcg∕kg∕ min ) + 10 × milrinone dose (mcg∕kg∕ min ) + 10,000 × vasopressin dose (units∕kg∕ min )

    + 100 × norepinephrine dose (mcg∕kg∕ min )

    Measured: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation

  2. Norepinephrine dose dynamics

    Norepinephrine dose dynamics (mcg/kg/min)

    Measured: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation

  3. Hemodynamic index dynamics

    Hemodynamic index: Mean arterial pressure (MAP) to Vasoactive Inotropic Score (VIS);

    VIS = dopamine dose (mcg∕kg∕ min ) + dobutamine dose (mcg∕kg∕ min ) + 100 × epinephrine dose (mcg∕kg∕ min ) + 10 × milrinone dose (mcg∕kg∕ min ) + 10,000 × vasopressin dose (units∕kg∕ min ) + 100 × norepinephrine dose (mcg∕kg∕ min )

    Measured: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation

  4. Horowitz index dynamics

    Arterial oxygen partial pressure (PaO2)/fraction of inspired oxygen (FiO2) ratio (Horowitz index) dynamics

    Measured: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation

  5. Lactate level dynamics

    Lactate level dynamics (mmol/l)

    Measured: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation

  6. Total bilirubin level dynamics

    Total bilirubin level dynamics (mcmol/l)

    Measured: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation

  7. Indirect bilirubin level dynamics

    Indirect bilirubin level dynamics (mcmol/l)

    Measured: Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation

  8. Direct bilirubin level dynamics

    Direct bilirubin level dynamics (mcmol/l)

    Measured: Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation

  9. Ferritin level dynamics

    Ferritin level dynamics (mcg/l)

    Measured: Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation

  10. Procalcitonin (PCT) level dynamics

    Procalcitonin (PCT) level dynamics (ng/ml)

    Measured: Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation

  11. C- reactive protein (CRP) level dynamics

    C- reactive protein (CRP) level dynamics (mg/l)

    Measured: Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation

  12. NLR (neutrophil-to-lymphocyte ratio) dynamics

    NLR (neutrophil-to-lymphocyte ratio) dynamics

    Measured: Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation

  13. PLR (Platelet-to-lymphocyte ratio) dynamics

    PLR (Platelet-to-lymphocyte ratio) dynamics

    Measured: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation

  14. TNF (Tumor necrosis factor-alpha) level dynamics

    TNF (Tumor necrosis factor-alpha) level dynamics (pg/ml)

    Measured: Assessed at 3 time points: before hemoadsorption initiation (baseline); 48 hours and 72 hours after hemoadsorption initiation

  15. IL 6 (Interleukin 6) level dynamics

    IL 6 (Interleukin 6) level dynamics (pg/ml)

    Measured: Assessed at 3 time points: before hemoadsorption initiation (baseline); 48 hours and 72 hours after hemoadsorption initiation

  16. IL 10 (Interleukin 10) level dynamics

    IL 10 (Interleukin 10) level dynamics (pg/ml)

    Measured: Time Frame: Assessed at 3 time points: before hemoadsorption initiation (baseline); 48 hours and 72 hours after hemoadsorption initiation

  17. 28 - days mortality

    28 - days mortality

    Measured: Will be calculated for 28 days after hemoadsorption initiation

  18. 90 - days mortality

    90 - days mortality

    Measured: Will be calculated for 90 days after hemoadsorption initiation

  19. SOFA (sequential organ failure assessment) dynamics

    MODS (multiple organ disfunction syndrome) dynamics majored by SOFA (sequential organ failure assessment) score

    Measured: Assessed at 4 time points: before hemoadsorption initiatioin (baseline); at 24, 48 and 120 hours after hemoadsorption initiation

  20. SOFA 2 (sequential organ failure assessment) dynamics

    MODS (multiple organ disfunction syndrome) dynamics majored by SOFA 2 (sequential organ failure assessment) score

    Measured: Assessed at 5 time points: before hemoadsorption initiatioin (baseline); at 24, 48, 72 and 120 hours after hemoadsorption initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2026
  2. Study start25 Jun 2026 (estimated)
  3. Primary completion25 Jun 2027 (estimated)
  4. Study completion25 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, pilot, multicenter, parallel-group randomized controlled trial. Participants are independently stratified into 2 parallel groups based on the Endotoxin activity Assay (EAA) level: Group 1- inflammatory mediatiors adsorption (EAA\<0.6), group 2- Endotoxin adsorption (EAA 0.6-0.9). Within each distinct group, participants are randomized in a 1:1 ratio to receive either a CytoSorb (subgroup 1)/Jafron HA 330 (subgroup 2) in group 1 or Toramyxin PMX 20R (subgroup 3)/Efferon LPS (subgroup 4) in group 2. Every patient will receive 2 procedures of hemoadsorption
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07661303
Sponsor's protocol ID
HAdSS
Acronym
HAdSS
Status last verified
Jun 2026
First submitted
16 Jun 2026
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 36634624

  • Mehta 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.

    PubMed 32104647

  • Rey 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.

    PubMed 37018802

  • Cruz 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.

    PubMed 19531784

  • Klein 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.

    PubMed 30470853

Questions about this trial

What is this clinical trial studying?

A study testing Efferon LPS, Toramyxin PMX 20R and Jafron HA 330 in people with Septic Shock, run by Moscow Multidisciplinary Clinical Center "Kommunarka" at 7 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aleksandr Burov, PHD (+79854215478, Aleksander.bour@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SOFA (sequential organ failure assessment) score (time frame: Assessed at 72 hours after hemoadsorption initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07661303, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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