SepsisNCT07889804
Quality of Life in Patients With Post-Sepsis Syndrome
An observational study of Sepsis, run by Efferon JSC at 5 sites in Russia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Efferon LPS
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 5 sitesRussia
- Study dates
- 1 Nov 2026to 1 Nov 2029
- Phase
- Observational
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with a documented episode of sepsis or septic shock requiring hospitalization and treatment in an intensive care unit (ICU)
Who may be able to join
- Documented episode of sepsis or septic shock requiring hospitalization and treatment in an intensive care unit (ICU).
- Sequential Organ Failure Assessment (SOFA) score ≥4 points during the ICU stay
- Discharge from the ICU and hospital after completion of treatment for sepsis or septic shock
- Montreal Cognitive Assessment (MoCA) score ≥26 points
- Availability for remote follow-up during the 1-year post-sepsis period following hospital discharge
- Ability to participate in remote visits, complete remote questionnaires (PROMIS questionnaire, depression and anxiety rating scales), and transmit them via electronic communication means.
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- Ability to understand and independently complete patient-reported outcome questionnaires, or to complete them with minimal assistance.
- Availability of information regarding whether hemoadsorption with Efferon® LPS was performed during hospitalization for sepsis or septic shock
- Signed informed consent for participation in the study and collection of follow-up data
Who cannot join
- Severe cognitive impairment, dementia, or other conditions that prevent the participant from understanding the questionnaire items and providing meaningful responses.
- Severe mental illness or other psychiatric conditions that, in the Investigator's opinion, may substantially affect the validity or reliability of patient-reported outcomes.
- Inability to maintain remote contact with the participant during the follow-up period.
- Palliative care status.
- Current participation in another clinical study that, in the Investigator's opinion, may affect the quality-of-life or psychological outcomes assessed in this study.
- Any other condition or circumstance that, in the Investigator's opinion, may interfere with the participant's ability to comply with study procedures or may compromise the reliability of the study data
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Russia5 sites
Botkin Hospital
Moscow
City Clinical Hospital No. 24 of the Moscow City Health Department
Moscow
N.I. Pirogov City Clinical Hospital No. 1
Moscow
N.V. Sklifosovsky Research Institute for Emergency Medicine
Moscow
V.P. Demikhov City Clinical Hospital No. 68
Moscow
About this study
Official title: Quality of Life in Patients With Post-Sepsis Syndrome: A Multicenter Observational Study
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.
Read the detailed description
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.
- Conditions
- Sepsis
- Being tested
- Efferon LPS
- Keywords
- Hemoadsorption, Extracorporeal therapy, LPS adsorption
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efferon LPSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Baseline therapy | Patients who received standard therapy for sepsis. RRT or plasma-based therapies, including plasmapheresis or plasma exchange, are permitted. | |
| Baseline therapy + Efferon LPS | 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. Receives: Device: Efferon LPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-12 month
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 1-12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Efferon JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vladimir Kulabukhov, PhD, MD, Principal investigator, N.V. Sklifosovsky Research Institute for Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889804
- Sponsor's protocol ID
- efferon-lps-2026-02
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No