An interventional study of Efferon LPS and Toramyxin PMX 20R in Septic Shock, sponsored by Moscow Multidisciplinary Clinical Center "Kommunarka". Not yet recruiting at 7 sites in Russia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Moscow Multidisciplinary Clinical Center "Kommunarka" · Not applicable, Interventional, and Treatment
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:
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.
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).
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 76 is close to the median of 79 across 636 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Moscow Multidisciplinary Clinical Center "Kommunarka" is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Inflammatory mediatiors adsorption with EAA \<0,6 with CytoSorb
Device: CytoSorb
Inflammatory mediatiors adsorption with EAA \<0,6 with Jafron HA 330
Device: Jafron HA 330
Endotoxin haemoadsorption with EAA \[0.6-0.9\] with Toramyxin PMX 20R
Device: Toramyxin PMX 20R
Endotoxin haemoadsorption with EAA \[0.6-0.9\] with Efferon LPS
Device: Efferon LPS
Blood purification with Efferon LPS
Blood purification with Toramyxin PMX 20R
Blood purification with Jafron HA 330
Blood purification with Jafron HA 330
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.
Time frame: Assessed at 72 hours after hemoadsorption initiation
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 )
Time frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
Norepinephrine dose dynamics
Norepinephrine dose dynamics (mcg/kg/min)
Time frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
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 )
Time frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
Horowitz index dynamics
Arterial oxygen partial pressure (PaO2)/fraction of inspired oxygen (FiO2) ratio (Horowitz index) dynamics
Time frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
Lactate level dynamics
Lactate level dynamics (mmol/l)
Time frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
Total bilirubin level dynamics
Total bilirubin level dynamics (mcmol/l)
Time frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
Indirect bilirubin level dynamics
Indirect bilirubin level dynamics (mcmol/l)
Time frame: Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
Direct bilirubin level dynamics
Direct bilirubin level dynamics (mcmol/l)
Time frame: Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
Ferritin level dynamics
Ferritin level dynamics (mcg/l)
Time frame: Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
Procalcitonin (PCT) level dynamics
Procalcitonin (PCT) level dynamics (ng/ml)
Time frame: Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
C- reactive protein (CRP) level dynamics
C- reactive protein (CRP) level dynamics (mg/l)
Time frame: Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
NLR (neutrophil-to-lymphocyte ratio) dynamics
NLR (neutrophil-to-lymphocyte ratio) dynamics
Time frame: Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
PLR (Platelet-to-lymphocyte ratio) dynamics
PLR (Platelet-to-lymphocyte ratio) dynamics
Time frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation
TNF (Tumor necrosis factor-alpha) level dynamics
TNF (Tumor necrosis factor-alpha) level dynamics (pg/ml)
Time frame: Assessed at 3 time points: before hemoadsorption initiation (baseline); 48 hours and 72 hours after hemoadsorption initiation
IL 6 (Interleukin 6) level dynamics
IL 6 (Interleukin 6) level dynamics (pg/ml)
Time frame: Assessed at 3 time points: before hemoadsorption initiation (baseline); 48 hours and 72 hours after hemoadsorption initiation
IL 10 (Interleukin 10) level dynamics
IL 10 (Interleukin 10) level dynamics (pg/ml)
Time frame: Time Frame: Assessed at 3 time points: before hemoadsorption initiation (baseline); 48 hours and 72 hours after hemoadsorption initiation
28 - days mortality
28 - days mortality
Time frame: Will be calculated for 28 days after hemoadsorption initiation
90 - days mortality
90 - days mortality
Time frame: Will be calculated for 90 days after hemoadsorption initiation
SOFA (sequential organ failure assessment) dynamics
MODS (multiple organ disfunction syndrome) dynamics majored by SOFA (sequential organ failure assessment) score
Time frame: Assessed at 4 time points: before hemoadsorption initiatioin (baseline); at 24, 48 and 120 hours after hemoadsorption initiation
SOFA 2 (sequential organ failure assessment) dynamics
MODS (multiple organ disfunction syndrome) dynamics majored by SOFA 2 (sequential organ failure assessment) score
Time frame: Assessed at 5 time points: before hemoadsorption initiatioin (baseline); at 24, 48, 72 and 120 hours after hemoadsorption initiation
Ventilator-free days
Ventilator-free days
Time frame: Will be calculated for 28 days after hemoadsorption initiation
Vasopressor-free days
Vasopressor-free days
Time frame: Will be calculated for 28 days after hemoadsorption initiation
Dialysis-free days
Dialysis-free days
Time frame: Will be calculated for 28 days after hemoadsorption initiation
Hospital length of stay
Hospital length of stay
Time frame: Will be calculated for 28 days after hemoadsorption initiation
Intensive care unit (ICU) length of stay
Intensive care unit (ICU) length of stay
Time frame: Will be calculated for 28 days after hemoadsorption initiation
AEs (adverse events)
The safety will be assessed by analysing the number of adverse events (AEs) where causal relationship with the intervention cannot be excluded, up until Day 28.
Time frame: Serious AEs will be reported up to Day 28
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
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.
Start is estimated for Jun 2026; primary completion for Jun 2027, 12 months later.
Of 164 non-industry interventional studies with no phase under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's planned 12 months is below that.
Counting every sponsor, half of 172 studies reached it within 25 months; a quarter within 12 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Moscow Multidisciplinary Clinical Center "Kommunarka"