Multicenter Observational Prospective Open Pilot Study of Changes in the Total Clearance of Antibacterial Agents During Hemoperfusion Using Efferon LPS in Patients With Sepsis

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Russian Federation
N. V. Sklifosovsky Moscow Research Institute of Emergency
RECRUITING
Moscow
N.I. Pirogov City Clinical Hospital No. 1
RECRUITING
Moscow
Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko
RECRUITING
Nizhny Novgorod
Perm regional clinical hospital
RECRUITING
Perm
Contact Information
Primary
Alexandr Shelehov-Kravchenko, PhD, MD
alexandr.shelehov@gmail.com
+0079636564765
Time Frame
Start Date: 2024-10-21
Estimated Completion Date: 2026-01-30
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Efferon JSC

This content was sourced from clinicaltrials.gov