Selective Lipopolysaccharide Hemosorption in Maternal Sepsis

NCT ID: NCT05711901

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-06-15

Brief 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. 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.

Conditions

Maternal sepsIs

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No Intervention: Baseline therapy

Basic therapy - the routine practice of an institution for the treatment of patients with maternal sepsis

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental: Basic therapy + Efferon LPS

Basic therapy is a routine practice of the institution for the treatment of patients with maternal sepsis plus extracorporeal hemoperfusion therapy (Efferon LPS)

Group Type: EXPERIMENTAL

Efferon LPS

Intervention Type: DEVICE

Hemoperfusion using continuous extracorporeal LPS adsorption with Efferon LPS therapeutic device during a period of 12h immediately following admission to the intensive care unit

Interventions

Efferon LPS

Hemoperfusion using continuous extracorporeal LPS adsorption with Efferon LPS therapeutic device during a period of 12h immediately following admission to the intensive care unit

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Efferon JSC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexey Pyregov, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Moscow Regional Perinatal Center

Locations

Krasnoyarsk Regional Clinical Hospital

Krasnoyarsk, , Russia

Moscow Regional Perinatal Center

Moscow, , Russia

National Medical Research Center named after V.I. Kulakov

Moscow, , Russia

Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko

Nizhny Novgorod, , Russia

Perm regional clinical hospital

Perm, , Russia

Surgut District Clinical Center for Maternity and Childhood Health

Surgut, , Russia

Perinatal Center of the Tyumen Region

Tyumen, , Russia

Countries

Russia

Other Identifiers

efferon-lps-2022-01

Identifier Type: -

Identifier Source: org_study_id