Clearance of Antibacterial Agents During Hemoperfusion in Patients With Sepsis

NCT06602245 | Completed

• 1 other identifier: efferon-lps-2024-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Sepsis; Septic Shock

Keywords

Sepsis; Septic shock; Antibiotic clearance; Hemoperfusion; Extracorporeal therapy; Lipopolysaccharide sorption

Outcome Measures

Primary Outcomes (1)

• Adsorption clearance of antibacterial drugs by the Efferon LPS

  Adsorption сlearance of antibacterial drugs by the Efferon LPS device, mL/min

  During hemoperfusion with Efferon LPS

Secondary Outcomes (2)

• Total clearance of antibacterial drugs during haemoperfusion with the Efferon LPS

  During hemoperfusion with Efferon LPS

• Contribution of adsorption clearance to the total clearance of antibacterial drugs

  During hemoperfusion with Efferon LPS

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Efferon JSC: lead

Study Sites (4)

N. V. Sklifosovsky Moscow Research Institute of Emergency

Moscow, Russia

Location

N.I. Pirogov City Clinical Hospital No. 1

Moscow, Russia

Location

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

Nizhny Novgorod, Russia

Location

Perm regional clinical hospital

Perm, Russia

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Sergey Rey, PhD, MD

  N. V. Sklifosovsky Moscow Research Institute of Emergency, Moscow, Russia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start: October 21, 2024
• Primary Completion: April 3, 2025
• Study Completion: April 6, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-12

Locations

RU (4)