NCT06602245

Clearance of Antibacterial Agents During Hemoperfusion in Patients With Sepsis

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: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Efferon JSC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2024-10-21
• Primary completion: 2025-04-03
• Completion: 2025-04-06
• First posted: 2024-09-19
• Last updated: 2025-12-02

Locations

4 sites across 1 country: Russia