Maternal sepsIsMINERVANCT05711901
Selective Lipopolysaccharide Hemosorption in Maternal Sepsis
A study testing Efferon LPS in people with Maternal sepsIs, run by Efferon JSC at 7 sites in Russia.
Trial summary
One of the major health problems in the world is sepsis, the number of cases of which, according to WHO, annually reaches 20-30 million. The prevalence and frequency of obstetric sepsis are quite pronounced. Thus, in Europe, up to 500,000 cases of sepsis are registered annually. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Maternal sepsIs
- What is being tested?
- Efferon LPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesRussia
- Study dates
- 1 Jan 2022to 15 Jun 2024
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- An established diagnosis of sepsis according to the criteria for SEPSIS-3, most likely Gram-negative etiology, at the time of inclusion.
- No more than 12 hours from the time of setting DS - Sepsis and/or Septic Shock.
- In case of septic shock:
- Hypotension requiring vasopressor support for at least 2 hours continuously and no more than 12 hours.
- In the absence of Septic shock, but in the presence of suspicion of sepsis (before the detection of flora) and organ dysfunction, inclusion in the clinical trial is based on 2 of the 4 SIRS criteria,
- SOFA ≥ 4 points.
Who cannot join
- Inability to obtain informed consent from the patient, family member or legal representative,
- The presence of a focus of non-sanitized surgical infection,
- The use of other methods of extracorporeal removal of LPS and inflammatory mediators in the treatment of septic shock (hemofilters with highly permeable and surface-modified membranes)
- In Septic Shock, failure to achieve or maintain a minimum mean arterial pressure (MAP) ≥ 65 mmHg. Art., despite vasopressor therapy and infusion therapy for 24 hours,
- End-stage renal disease and need for chronic dialysis.
- Acute pulmonary embolism
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- Transfusion reaction,
- Severe congestive heart failure,
- Uncontrolled bleeding (acute blood loss in the last 24 hours),
- Severe granulocytopenia (white blood cell count less than 500 cells/mm3),
- Any other condition that, in the opinion of the investigator, would prevent the patient from being a suitable candidate for inclusion in the study (eg terminal chronic disease).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Russia7 sites
Krasnoyarsk Regional Clinical Hospital
Krasnoyarsk
Moscow Regional Perinatal Center
Moscow
National Medical Research Center named after V.I. Kulakov
Moscow
Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko
Nizhny Novgorod
Perm regional clinical hospital
Perm
Surgut District Clinical Center for Maternity and Childhood Health
Surgut
Perinatal Center of the Tyumen Region
Tyumen
About this study
Official title: Multicenter Observational Prospective Study of the Efficacy and Safety of Selective Lipopolysaccharide Hemosorption Using the Efferon LPS Device in Maternal Sepsis Complicated by Organ Dysfunction and/or Septic Shock
One of the major health problems in the world is sepsis, the number of cases of which, according to WHO, annually reaches 20-30 million.
The prevalence and frequency of obstetric sepsis are quite pronounced. Thus, in Europe, up to 500,000 cases of sepsis are registered annually. In Russia, the frequency of obstetric purulent-inflammatory diseases in the structure of maternal mortality ranges from 5 to 26%, according to some data - up to 45-75%. In the structure of maternal mortality, this pathology is in second or third place. Numerous studies have shown that the use of extracorporeal sorption methods that eliminate endotoxin and cytokines improves the results of treatment of patients with septic shock. The main goal of the study was to obtain new data on the efficacy and safety of using the Efferon LPS device for hemosorption of lipopolysaccharides during extracorporeal detoxification in patients with obstetric sepsis.
Read the detailed description
One of the major health problems in the world is sepsis, the number of cases of which, according to WHO, annually reaches 20-30 million. One third of patients admitted to the ICU were patients with infection, a fifth of whom developed septic shock, the proportion of hospital sepsis was 46.6%, and death occurred in 30.4% of patients with infection.
The prevalence and incidence of obstetric sepsis is also pronounced. In Europe, up to 500,000 cases of sepsis are registered annually. In Russia, the frequency of obstetric purulent-inflammatory diseases in the structure of maternal mortality ranges from 5 to 26%, according to some data - up to 75%. In the structure of maternal mortality, this pathology is in second or third place.
Most often, postpartum sepsis occurs against the background of endometritis (90%), much less often against the background of a wound infection, mastitis, urinary tract infection (apostematous nephritis) or post-injection abscess. Every year, one million newborns die due to maternal infections, in particular maternal sepsis. Endotoxin, one of the most potent mediators of sepsis, is found in high concentrations in about 50% of patients with septic shock.
Despite clear progress in intensive care, the prognosis in patients with endotoxemia and septic shock remains unfavorable.
Hemoperfusion or hemoadsorption is a method of extracorporeal removal of toxic substances from the blood by their adsorption on a porous material. The hemosorption method can be a good addition or replacement to the classical methods of hemofiltration and hemodialysis, if the diffusion or convection of toxic substances through the membrane is not effective enough. Currently, using hemosorbents based on highly cross-linked copolymers of styrene and divinylbenzene, it is possible to remove endo- and exotoxins in acute and chronic renal and hepatic insufficiency, eliminate intoxication with pharmacological drugs, drugs and poisons, and also remove cytokines that are formed in excess during sepsis and systemic inflammatory diseases. syndrome of another etiology.
Numerous studies have shown that the use of endotoxin-eliminating methods of extracorporeal sorption improves outcomes in patients with sepsis and septic shock.
Efferon LPS is a device for extracorporeal blood purification by direct hemoperfusion. Detoxification is carried out by selective sorption of lipopolysaccharides (bacterial endotoxins).
The purpose of this observational study is to evaluate the efficacy and safety of multimodal (lipopolysaccharide + cytokine) sorption using the Efferon LPS device in patients with obstetric sepsis.
- Conditions
- Maternal sepsIs
- Being tested
- Efferon LPS
- Keywords
- septic shock, maternal sepsIs, lipopolysaccharide sorption, obstetric sepsis
- Medical subject headings
- Pregnancy Complications, Infectious, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efferon LPSDevice
Hemoperfusion using continuous extracorporeal LPS adsorption with Efferon LPS therapeutic device during a period of 12h immediately following admission to the intensive care unit
| Study group | Role | What they receive |
|---|---|---|
| No Intervention: Baseline therapy | No intervention | Basic therapy - the routine practice of an institution for the treatment of patients with maternal sepsis |
| Experimental: Basic therapy + Efferon LPS | Experimental | Basic therapy is a routine practice of the institution for the treatment of patients with maternal sepsis plus extracorporeal hemoperfusion therapy (Efferon LPS) Receives: Device: Efferon LPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Efferon LPS hemoperfusion on SOFA (Sequential Organ Failure Assessment) scores in patients with obstetric sepsis.
The value of indicators on the SOFA (Sequential Organ Failure Assessment) scale every 24 hours ± 1 hour from the start of hemoperfusion (0 hour) to 72 hours. The SOFA index is equal to the sum of six indicators. The higher the score, the greater the insufficiency of the system being assessed. The higher the overall index, the greater the degree of multiorgan dysfunction. Violation of the function of each organ (system) is assessed separately in dynamics against the background of intensive therapy. With a score of no more than 12, multiple organ dysfunctions are assumed, 13-17 points indicate the transition of dysfunction to insufficiency, a score of about 24 indicates a high probability of death. The lower the SOFA index, the less pronounced organ failure and the better the patient's survival prognosis.
Measured: 1-72 hours
The effect of Efferon-LPS hemoperfusion on hemodynamic parameters in patients with obstetric sepsis
Event criteria: end of vasopressor support (maintenance of effect for 4 hours)
Measured: Time (number of hours) from enrollment in the study to the end of vasopressor support during 14 days of follow-up
Secondary outcomes (3)
Effect of LPS Efferon hemoperfusion on endotoxin activity
Value of endotoxin levels every 24 hours ± 1 hour from the start of hemoperfusion (hour 0) to 72 hours
Measured: 1-72 hours
Effect of the Efferon LPS hemoperfusion on pulmonary oxygen metabolism function
Value of oxygenation index (Pa02 / Fi02 (Pa) every 24 hours ± 1 hour from the start of hemoperfusion (hour 0) to 72 hours.
Measured: 1-72 hours
Effect of the Efferon LPS hemoperfusion on the length of stay in the ICU
Time (number of days) from enrollment in the study to transfer from the ICU within 14 days.
Measured: 1-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Jan 2022
- Primary completion1 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter prospective study with a control group to evaluate the efficacy and safety of LPS sorption using the Efferon LPS device in postpartum sepsis
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Efferon JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexey Pyregov, PhD, MD, Principal investigator, Moscow Regional Perinatal Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711901
- Sponsor's protocol ID
- efferon-lps-2022-01
- Acronym
- MINERVA
- Status last verified
- Jun 2024
- First submitted
- 13 Jan 2023
- Last updated
- 25 Jun 2024
- 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 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Observational Prospective Study of the Efficacy and Safety of Selective Lipopolysaccharide Hemosorption Using the Efferon LPS Device in Maternal Sepsis Complicated by Organ Dysfunction and/or Septic Shock
- ClinicalTrials.gov ID
- NCT05711901
- Acronym / sponsor ID
- MINERVA / efferon-lps-2022-01
- Conditions
- Maternal sepsIs
- Keywords
- septic shock, maternal sepsIs, lipopolysaccharide sorption, obstetric sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Efferon JSCIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 3 Feb 2023 (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 major health problems in the world is sepsis, the number of cases of which, according to WHO, annually reaches 20-30 million.
The prevalence and frequency of obstetric sepsis are quite pronounced. Thus, in Europe, up to 500,000 cases of sepsis are registered annually. In Russia, the frequency of obstetric purulent-inflammatory diseases in the structure of maternal mortality ranges from 5 to 26%, according to some data - up to 45-75%. In the structure of maternal mortality, this pathology is in second or third place. Numerous studies have shown that the use of extracorporeal sorption methods that eliminate endotoxin and cytokines improves the results of treatment of patients with septic shock. The main goal of the study was to obtain new data on the efficacy and safety of using the Efferon LPS device for hemosorption of lipopolysaccharides during extracorporeal detoxification in patients with obstetric sepsis.
Detailed description
One of the major health problems in the world is sepsis, the number of cases of which, according to WHO, annually reaches 20-30 million. One third of patients admitted to the ICU were patients with infection, a fifth of whom developed septic shock, the proportion of hospital sepsis was 46.6%, and death occurred in 30.4% of patients with infection.
The prevalence and incidence of obstetric sepsis is also pronounced. In Europe, up to 500,000 cases of sepsis are registered annually. In Russia, the frequency of obstetric purulent-inflammatory diseases in the structure of maternal mortality ranges from 5 to 26%, according to some data - up to 75%. In the structure of maternal mortality, this pathology is in second or third place.
Most often, postpartum sepsis occurs against the background of endometritis (90%), much less often against the background of a wound infection, mastitis, urinary tract infection (apostematous nephritis) or post-injection abscess. Every year, one million newborns die due to maternal infections, in particular maternal sepsis. Endotoxin, one of the most potent mediators of sepsis, is found in high concentrations in about 50% of patients with septic shock.
Despite clear progress in intensive care, the prognosis in patients with endotoxemia and septic shock remains unfavorable.
Hemoperfusion or hemoadsorption is a method of extracorporeal removal of toxic substances from the blood by their adsorption on a porous material. The hemosorption method can be a good addition or replacement to the classical methods of hemofiltration and hemodialysis, if the diffusion or convection of toxic substances through the membrane is not effective enough. Currently, using hemosorbents based on highly cross-linked copolymers of styrene and divinylbenzene, it is possible to remove endo- and exotoxins in acute and chronic renal and hepatic insufficiency, eliminate intoxication with pharmacological drugs, drugs and poisons, and also remove cytokines that are formed in excess during sepsis and systemic inflammatory diseases. syndrome of another etiology.
Numerous studies have shown that the use of endotoxin-eliminating methods of extracorporeal sorption improves outcomes in patients with sepsis and septic shock.
Efferon LPS is a device for extracorporeal blood purification by direct hemoperfusion. Detoxification is carried out by selective sorption of lipopolysaccharides (bacterial endotoxins).
The purpose of this observational study is to evaluate the efficacy and safety of multimodal (lipopolysaccharide + cytokine) sorption using the Efferon LPS device in patients with obstetric sepsis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter prospective study with a control group to evaluate the efficacy and safety of LPS sorption using the Efferon LPS device in postpartum sepsis
| Arm | Type | Receives |
|---|---|---|
| No Intervention: Baseline therapy | No intervention | –Basic therapy - the routine practice of an institution for the treatment of patients with maternal sepsis |
| Experimental: Basic therapy + Efferon LPS | Experimental | Device: Efferon LPSBasic therapy is a routine practice of the institution for the treatment of patients with maternal sepsis plus extracorporeal hemoperfusion therapy (Efferon LPS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
- An established diagnosis of sepsis according to the criteria for SEPSIS-3, most likely Gram-negative etiology, at the time of inclusion.
- No more than 12 hours from the time of setting DS - Sepsis and/or Septic Shock.
- Hypotension requiring vasopressor support for at least 2 hours continuously and no more than 12 hours.
- In the absence of Septic shock, but in the presence of suspicion of sepsis (before the detection of flora) and organ dysfunction, inclusion in the clinical trial is based on 2 of the 4 SIRS criteria,
Key exclusion criteria (11 listed)
- Inability to obtain informed consent from the patient, family member or legal representative,
- The presence of a focus of non-sanitized surgical infection,
- The use of other methods of extracorporeal removal of LPS and inflammatory mediators in the treatment of septic shock (hemofilters with highly permeable and surface-modified membranes)
- In Septic Shock, failure to achieve or maintain a minimum mean arterial pressure (MAP) ≥ 65 mmHg. Art., despite vasopressor therapy and infusion therapy for 24 hours,
- End-stage renal disease and need for chronic dialysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efferon LPSHemoperfusion using continuous extracorporeal LPS adsorption with Efferon LPS therapeutic device during a period of 12h immediately following admission to the intensive care unit | Device | Experimental: Basic therapy + Efferon LPS |
Primary outcome
Effect of Efferon LPS hemoperfusion on SOFA (Sequential Organ Failure Assessment) scores in patients with obstetric sepsis.
Time frame: 1-72 hours
The value of indicators on the SOFA (Sequential Organ Failure Assessment) scale every 24 hours ± 1 hour from the start of hemoperfusion (0 hour) to 72 hours. The SOFA index is equal to the sum of six indicators. The higher the score, the greater the insufficiency of the system being assessed. The higher the overall index, the greater the degree of multiorgan dysfunction. Violation of the function of each organ (system) is assessed separately in dynamics against the background of intensive therapy. With a score of no more than 12, multiple organ dysfunctions are assumed, 13-17 points indicate the transition of dysfunction to insufficiency, a score of about 24 indicates a high probability of death. The lower the SOFA index, the less pronounced organ failure and the better the patient's survival prognosis.
The effect of Efferon-LPS hemoperfusion on hemodynamic parameters in patients with obstetric sepsis
Time frame: Time (number of hours) from enrollment in the study to the end of vasopressor support during 14 days of follow-up
Event criteria: end of vasopressor support (maintenance of effect for 4 hours)
3 secondary outcomes
Effect of LPS Efferon hemoperfusion on endotoxin activity
Time frame: 1-72 hours
Effect of the Efferon LPS hemoperfusion on pulmonary oxygen metabolism function
Time frame: 1-72 hours
Effect of the Efferon LPS hemoperfusion on the length of stay in the ICU
Time frame: 1-14 days
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 25 Jun 2024.
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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.
Alexey Pyregov, PhD, MD principal investigator
Moscow Regional Perinatal Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efferon LPS in people with Maternal sepsIs, run by Efferon JSC 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 7 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 25 Jun 2024. 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?
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?
Effect of Efferon LPS hemoperfusion on SOFA (Sequential Organ Failure Assessment) scores in patients with obstetric sepsis. (time frame: 1-72 hours). The study lists 2 primary outcomes in all. 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 25 Jun 2024.