SepsisNCT06602245
Clearance of Antibacterial Agents During Hemoperfusion in Patients With Sepsis
An observational study of Sepsis and Septic Shock, run by Efferon JSC at 4 sites in Russia.
Trial summary
One of the significants health problems in the world is sepsis, with the number of cases reaching 20-30 million per year, according to the WHO. Numerous studies have shown that the use of extracorporeal methods improves outcomes in patients with septic shock. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis, Septic Shock
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 4 sitesRussia
- Study dates
- 21 Oct 2024to 6 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: The expected number of study subjects is 30 adult patients with sepsis and/or septic shock (presumably of Gramnegative aetiology and any localisation). It is planned to recruit : * 10 patients receiving meropenem * 10 patients receiving vancomycin * 10 patients receiving linezolid. Patients may receive more than one of these antibiotics at the same time, in which case they will be included in several subpopulations of the study.
Who may be able to join
- Patient weight greater than 40 kg.
- Diagnosis of sepsis and/or septic shock according to CEPSIS-3 criteria (2016), presumed (at time of enrolment) to be of Gram-negative aetiology, requiring, in the opinion of the investigator, isolated lipopolysaccharide hemoperfusion.
Who cannot join
- Failure to obtain informed consent from the patient, family member or legal representative.
- Any patient condition requiring other methods of renal replacement therapy (e.g. hemodialysis, hemofiltration, hemodiafiltration).
- Pregnancy, breastfeeding period.
- General contraindications to extracorporeal treatments.
- Any other condition that, in the opinion of the investigator, would prevent the patient from being a suitable candidate for inclusion in the study (e.g. terminal chronic disease).
- Development of an adverse event, including a serious adverse event; individual intolerance to the investigational product, hypersensitivity to the components of the product due to which further participation in the study is not possible.
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- Continued participation in the study is not, in the opinion of the investigator, in the best interests of the patient\'s health.
- The patient, in the opinion of the investigator, fails to comply with the requirements of the study procedures.
- The presence of protocol deviations that, in the opinion of the Sponsor and the investigator, require withdrawal of the participant from the study.
- A positive pregnancy test result at any time during the study.
- Use of any other methods of renal replacement therapy and extracorporeal hemocorrection during isolated hemoperfusion with the Efferon LPS device.
Trial locations and contacts
4 sites in 1 country.
Russia4 sites
N. V. Sklifosovsky Moscow Research Institute of Emergency
Moscow
N.I. Pirogov City Clinical Hospital No. 1
Moscow
Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko
Nizhny Novgorod
Perm regional clinical hospital
Perm
About this study
Official title: Multicenter Observational Prospective Open Pilot Study of Changes in the Total Clearance of Antibacterial Agents During Hemoperfusion Using Efferon LPS in Patients With Sepsis
One of the significants health problems in the world is sepsis, with the number of cases reaching 20-30 million per year, according to the WHO. Numerous studies have shown that the use of extracorporeal methods improves outcomes in patients with septic shock. Safety parameters are particularly important in deciding whether to initiate such therapy in a patient. To date, numerous post-marketing observations and data from the published literature have shown no serious adverse hemoperfusion events, with the exception of occasional thrombocytopenia. However, the potential removal of life-saving drugs, such as antibiotics, by hemoperfusion in patients with sepsis remains poorly understood and requires special attention.
The main objective of this study is to evaluate the incremental increase in total clearance of antibacterial drugs during haemoperfusion using the Efferon LPS device in patients with sepsis.
Read the detailed description
Sepsis is a major public health problem worldwide, with 20-30 million cases per year according to the WHO. Lipopolysaccharide adsorption is used for the rapid resolution of the severe symptom complex associated with sepsis and septic shock. To date, numerous post-approval observations and data from the published literature have shown no serious adverse hemoperfusion events, except for occasional thrombocytopenia. At the same time, it is very important in the treatment of sepsis to start antibacterial drugs as early as possible, and the effect of lipopolysaccharide and cytokine adsorption on the clearance of antibacterial drugs remains poorly understood.
Little is known about the effects of modern sorption devices on the pharmacokinetics of antimicrobial drugs. The results obtained in animals and reports of single patient studies, as well as the results of in vitro studies, cannot be extrapolated to the general population of sepsis patients receiving hemoperfusion for the underlying disease. The observations need to be confirmed in clinical trials in patients with sepsis and septic shock in order to develop appropriate recommendations for dose adjustment of the antibacterial drugs used.
The present study in patients with sepsis and/or septic shock is designed to determine the effect of lipopolysaccharide adsorption using the Efferon LPS device on the pharmacokinetics of several antimicrobial agents (meropenem, vancomycin and linezolid).
- Conditions
- Sepsis, Septic Shock
- Keywords
- Sepsis, Septic shock, Antibiotic clearance, Hemoperfusion, Extracorporeal therapy, Lipopolysaccharide sorption
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hemoperfusion and antibiotic tratment groups | The trial will be conducted in one group of patients. Patients who are undergoing antibiotic therapy and hemoperfusion will be included in the study. 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. All patients included undergo a single extracorporeal blood purification for 4-12 hours in the form of isolated hemoperfusion using the Efferon LPS device in combination with antibiotic therapy. The hemoperfusion must be started no later than 30 minutes after the end of the antibacterial drug administration, otherwise the patient will be excluded from the study. Antibacterial drugs are administered by infusion according to the instructions for use: * Meropenem within 30 minutes * Vancomycin within 60 minutes * Linezolid within 60 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adsorption clearance of antibacterial drugs by the Efferon LPS
Adsorption сlearance of antibacterial drugs by the Efferon LPS device, mL/min
Measured: During hemoperfusion with Efferon LPS
Secondary outcomes (2)
Total clearance of antibacterial drugs during haemoperfusion with the Efferon LPS
Total clearance of antibacterial drugs (adsorption clearance + patient system clearance), mL/min
Measured: During hemoperfusion with Efferon LPS
Contribution of adsorption clearance to the total clearance of antibacterial drugs
Efferon LPS device adsorption clearance relative to total clearance, %
Measured: During hemoperfusion with Efferon LPS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start21 Oct 2024
- Primary completion3 Apr 2025
- Study completion6 Apr 2025
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Efferon JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sergey Rey, PhD, MD, Principal investigator, N. V. Sklifosovsky Moscow Research Institute of Emergency, Moscow, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602245
- Sponsor's protocol ID
- efferon-lps-2024-01
- Status last verified
- Dec 2025
- First submitted
- 16 Sep 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Observational Prospective Open Pilot Study of Changes in the Total Clearance of Antibacterial Agents During Hemoperfusion Using Efferon LPS in Patients With Sepsis
- ClinicalTrials.gov ID
- NCT06602245
- Acronym / sponsor ID
- efferon-lps-2024-01
- Conditions
- Sepsis, Septic Shock
- Keywords
- Sepsis, Septic shock, Antibiotic clearance, Hemoperfusion, Extracorporeal therapy, Lipopolysaccharide sorption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Efferon JSCIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 3 Apr 2025 (actual)
- Study completion
- 6 Apr 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One of the significants health problems in the world is sepsis, with the number of cases reaching 20-30 million per year, according to the WHO. Numerous studies have shown that the use of extracorporeal methods improves outcomes in patients with septic shock. Safety parameters are particularly important in deciding whether to initiate such therapy in a patient. To date, numerous post-marketing observations and data from the published literature have shown no serious adverse hemoperfusion events, with the exception of occasional thrombocytopenia. However, the potential removal of life-saving drugs, such as antibiotics, by hemoperfusion in patients with sepsis remains poorly understood and requires special attention.
The main objective of this study is to evaluate the incremental increase in total clearance of antibacterial drugs during haemoperfusion using the Efferon LPS device in patients with sepsis.
Detailed description
Sepsis is a major public health problem worldwide, with 20-30 million cases per year according to the WHO. Lipopolysaccharide adsorption is used for the rapid resolution of the severe symptom complex associated with sepsis and septic shock. To date, numerous post-approval observations and data from the published literature have shown no serious adverse hemoperfusion events, except for occasional thrombocytopenia. At the same time, it is very important in the treatment of sepsis to start antibacterial drugs as early as possible, and the effect of lipopolysaccharide and cytokine adsorption on the clearance of antibacterial drugs remains poorly understood.
Little is known about the effects of modern sorption devices on the pharmacokinetics of antimicrobial drugs. The results obtained in animals and reports of single patient studies, as well as the results of in vitro studies, cannot be extrapolated to the general population of sepsis patients receiving hemoperfusion for the underlying disease. The observations need to be confirmed in clinical trials in patients with sepsis and septic shock in order to develop appropriate recommendations for dose adjustment of the antibacterial drugs used.
The present study in patients with sepsis and/or septic shock is designed to determine the effect of lipopolysaccharide adsorption using the Efferon LPS device on the pharmacokinetics of several antimicrobial agents (meropenem, vancomycin and linezolid).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemoperfusion and antibiotic tratment groups | – | –The trial will be conducted in one group of patients. Patients who are undergoing antibiotic therapy and hemoperfusion will be included in the study. 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. All patients included undergo a single extracorporeal blood purification for 4-12 hours in the form of isolated hemoperfusion using the Efferon LPS device in combination with antibiotic therapy. The hemoperfusion must be started no later than 30 minutes after the end of the antibacterial drug administration, otherwise the patient will be excluded from the study. Antibacterial drugs are administered by infusion according to the instructions for use: * Meropenem within 30 minutes * Vancomycin within 60 minutes * Linezolid within 60 minutes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The expected number of study subjects is 30 adult patients with sepsis and/or septic shock (presumably of Gramnegative aetiology and any localisation). It is planned to recruit : * 10 patients receiving meropenem * 10 patients receiving vancomycin * 10 patients receiving linezolid. Patients may receive more than one of these antibiotics at the same time, in which case they will be included in several subpopulations of the study.
Key inclusion criteria (2 listed)
- Patient weight greater than 40 kg.
- Diagnosis of sepsis and/or septic shock according to CEPSIS-3 criteria (2016), presumed (at time of enrolment) to be of Gram-negative aetiology, requiring, in the opinion of the investigator, isolated lipopolysaccharide hemoperfusion.
Key exclusion criteria (11 listed)
- Failure to obtain informed consent from the patient, family member or legal representative.
- Any patient condition requiring other methods of renal replacement therapy (e.g. hemodialysis, hemofiltration, hemodiafiltration).
- Pregnancy, breastfeeding period.
- General contraindications to extracorporeal treatments.
- Any other condition that, in the opinion of the investigator, would prevent the patient from being a suitable candidate for inclusion in the study (e.g. terminal chronic disease).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adsorption clearance of antibacterial drugs by the Efferon LPS
Time frame: During hemoperfusion with Efferon LPS
Adsorption сlearance of antibacterial drugs by the Efferon LPS device, mL/min
2 secondary outcomes
Total clearance of antibacterial drugs during haemoperfusion with the Efferon LPS
Time frame: During hemoperfusion with Efferon LPS
Contribution of adsorption clearance to the total clearance of antibacterial drugs
Time frame: During hemoperfusion with Efferon LPS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergey Rey, PhD, MD principal investigator
N. V. Sklifosovsky Moscow Research Institute of Emergency, Moscow, Russia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Efferon JSC at 4 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 2 inclusion and 11 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: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adsorption clearance of antibacterial drugs by the Efferon LPS (time frame: During hemoperfusion with Efferon LPS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2025.