Clearance of Antibacterial Agents During Hemoperfusion in Patients With Sepsis

NCT ID: NCT06602245

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-21
• Study Completion Date: 2025-04-06

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.

Detailed Description

Sepsis is a major public health problem worldwide, with 20-30 million cases per year according to the WHO. Lipopolysaccharide adsorption is used for the rapid resolution of the severe symptom complex associated with sepsis and septic shock. To date, numerous post-approval observations and data from the published literature have shown no serious adverse hemoperfusion events, except for occasional thrombocytopenia. At the same time, it is very important in the treatment of sepsis to start antibacterial drugs as early as possible, and the effect of lipopolysaccharide and cytokine adsorption on the clearance of antibacterial drugs remains poorly understood.

Little is known about the effects of modern sorption devices on the pharmacokinetics of antimicrobial drugs. The results obtained in animals and reports of single patient studies, as well as the results of in vitro studies, cannot be extrapolated to the general population of sepsis patients receiving hemoperfusion for the underlying disease. The observations need to be confirmed in clinical trials in patients with sepsis and septic shock in order to develop appropriate recommendations for dose adjustment of the antibacterial drugs used.

The present study in patients with sepsis and/or septic shock is designed to determine the effect of lipopolysaccharide adsorption using the Efferon LPS device on the pharmacokinetics of several antimicrobial agents (meropenem, vancomycin and linezolid).

Conditions

Sepsis; Septic Shock

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Any other condition that, in the opinion of the investigator, would prevent the patient from being a suitable candidate for inclusion in the study (e.g. terminal chronic disease).
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Efferon JSC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sergey Rey, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

N. V. Sklifosovsky Moscow Research Institute of Emergency

Moscow, , Russia

N.I. Pirogov City Clinical Hospital No. 1

Moscow, , Russia

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

Nizhny Novgorod, , Russia

Perm regional clinical hospital

Perm, , Russia

Countries

Russia

Other Identifiers

efferon-lps-2024-01

Identifier Type: -

Identifier Source: org_study_id