An observational study in Sepsis, sponsored by Efferon JSC. Not yet recruiting at 5 sites in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Efferon JSC · Observational
The aim of the study is to assess health status and quality of life during the post-sepsis period using patient-reported outcome measures. Patients will be classified into two groups according to treatment received during hospitalization for sepsis or septic shock: those who received standard-of-care treatment alone and those who additionally received Efferon® LPS hemoadsorption. The study will compare post-sepsis outcomes between the two groups over a 12-month follow-up period.
The long-term consequences of sepsis are collectively referred to as post-sepsis syndrome. Post-sepsis syndrome is characterized by a broad range of persistent physical, cognitive, and psychological symptoms, including fatigue, weakness, memory impairment, depression, and anxiety. Recovery after sepsis is often incomplete, and a substantial proportion of sepsis survivors experience persistent impairments in physical and mental health for months or years after hospital discharge.
The Efferon® LPS device is designed for hemoadsorption of lipopolysaccharides and a broad range of inflammatory mediators from the bloodstream. It is hypothesized that reducing the circulating burden of biologically active inflammatory mediators during the acute phase of sepsis through multimodal hemoadsorption may influence the subsequent post-sepsis trajectory. This may contribute to attenuation of persistent inflammation and immune dysregulation, support restoration of immune homeostasis, and reduce chronic systemic stress, potentially improving physical and psychological functioning and quality of life after hospital discharge.
The present study will compare patient-reported health status, quality of life, depressive and anxiety symptoms, and other post-sepsis outcomes between patients who received multimodal hemoadsorption using Efferon® LPS during treatment for sepsis or septic shock and patients who received standard-of-care treatment without Efferon® LPS.
1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.
This study's planned enrollment of 300 is above the median of 160 across 957 observational studies indexed under Sepsis.
Browse Sepsis studies →Efferon JSC is the lead sponsor of 20 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients with a documented episode of sepsis or septic shock requiring hospitalization and treatment in an intensive care unit (ICU)
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:
Patients who received standard therapy for sepsis. RRT or plasma-based therapies, including plasmapheresis or plasma exchange, are permitted.
Patients who received Efferon® LPS hemoadsorption during treatment for sepsis, either alone or in combination with renal replacement therapy (RRT). Concomitant plasma-based therapies, including plasmapheresis or plasma exchange, are permitted.
Device: Efferon LPS
Efferon LPS, a medical device, which is a single-use cartridge filled with a polymeric adsorbent that selectively adsorbs endotoxin via surface-immobilized ligand and excessive cytokines via its intrinsic porosity.
Number of deaths and hospital readmissions during the 12-month follow-up period
Patient status, including survival, hospital readmissions, and palliative care status, assessed during the 12-month follow-up period after hospital discharge
Time frame: 1-12 month
Overall health status and quality of life during the post-sepsis period (PROMIS score)
Patient-Reported Outcomes Measurement Information System (PROMIS Global-10) score. Higher T-scores indicate better health. A score of 50 represents the population mean. Scores above 50 indicate better-than-average health status. Scores from 40 to 50 indicate average to mildly reduced health status. Scores below 40 indicate reduced health status.
Time frame: 1-12 month
Severity of depressive symptoms during the post-sepsis period (PHQ-9 score)
The PHQ-9 score ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms. Scores of 0-4 indicate minimal or no depressive symptoms, 5-9 indicate mild depressive symptoms, 10-14 indicate moderate depressive symptoms, 15-19 indicate moderately severe depressive symptoms, and 20-27 indicate severe depressive symptoms.
Time frame: 1-12 month
Severity of anxiety symptoms during the post-sepsis period (GAD-7 score)
The GAD-7 score ranges from 0 to 21, with higher scores indicating greater severity of anxiety symptoms. Scores of 0-4 indicate minimal anxiety, 5-9 indicate mild anxiety, 10-14 indicate moderate anxiety, and 15-21 indicate severe anxiety.
Time frame: 1-12 month
Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.
Of 44 industry-sponsored observational studies under Sepsis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 44. This study's planned 24 months is above that.
Counting every sponsor, half of 452 studies reached it within 29 months; a quarter within 12 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Efferon JSC