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Selective Lipopolysaccharide Hemosorption in Maternal Sepsis

NCT05711901 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-06-25

No results posted yet for this study

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.

Conditions

  • Maternal sepsIs

Interventions

DEVICE

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

Sponsors & Collaborators

  • Efferon JSC

    lead INDUSTRY

Principal Investigators

  • Alexey Pyregov, PhD, MD · Moscow Regional Perinatal Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-06-01
Completion
2024-06-15

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05711901 on ClinicalTrials.gov