Selective Lipopolysaccharide Hemosorption in Maternal Sepsis

NCT05711901 | Completed

• 1 other identifier: efferon-lps-2022-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

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.

Conditions

Maternal sepsIs

Keywords

septic shock; maternal sepsIs; lipopolysaccharide sorption; obstetric sepsis

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  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

  1-72 hours

• Effect of the Efferon LPS hemoperfusion on pulmonary oxygen metabolism function

  1-72 hours

• Effect of the Efferon LPS hemoperfusion on the length of stay in the ICU

  1-14 days

Study Arms (2)

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)

Device: Efferon LPS

Interventions

Efferon LPS 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

Experimental: Basic therapy + Efferon LPS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• 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.
• SOFA ≥ 4 points.

You may not qualify if:

• 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),

Sponsors & Collaborators

• Efferon JSC: lead

Study Sites (7)

Krasnoyarsk Regional Clinical Hospital

Krasnoyarsk, Russia

Location

Moscow Regional Perinatal Center

Moscow, Russia

Location

National Medical Research Center named after V.I. Kulakov

Moscow, Russia

Location

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

Nizhny Novgorod, Russia

Location

Perm regional clinical hospital

Perm, Russia

Location

Surgut District Clinical Center for Maternity and Childhood Health

Surgut, Russia

Location

Perinatal Center of the Tyumen Region

Tyumen, Russia

Location

MeSH Terms

Conditions

Pregnancy Complications, Infectious; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Alexey Pyregov, PhD, MD

  Moscow Regional Perinatal Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter prospective study with a control group to evaluate the efficacy and safety of LPS sorption using the Efferon LPS device in postpartum sepsis

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 3, 2023
• Study Start: January 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 15, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

RU (7)