Evaluating antibiotic clearance during hemoperfusion in sepsis patients
Multicenter Observational Prospective Open Pilot Study of Changes in the Total Clearance of Antibacterial Agents During Hemoperfusion Using Efferon LPS in Patients With Sepsis
This study tests how well certain antibiotics are removed from the blood during a treatment called hemoperfusion in patients with sepsis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Efferon JSC Industry-sponsored |
| Locations | 4 sites (Moscow and 3 other locations) |
| Trial ID | NCT06602245 on ClinicalTrials.gov |
What this trial studies
This study aims to assess how effectively antibacterial drugs are cleared from the bloodstream during hemoperfusion in patients suffering from sepsis and septic shock. Using the Efferon LPS device, the research will focus on the pharmacokinetics of key antibiotics such as meropenem, vancomycin, and linezolid. Given the high incidence of sepsis globally, understanding the interaction between hemoperfusion and antibiotic clearance is crucial for optimizing treatment protocols. The study will involve patients diagnosed with sepsis of presumed Gram-negative origin who are undergoing this specific therapy.
Who should consider this trial
Good fit: Ideal candidates include adults over 40 kg diagnosed with sepsis or septic shock of Gram-negative origin requiring hemoperfusion.
Not a fit: Patients with conditions necessitating other forms of renal replacement therapy or those with contraindications to extracorporeal treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dosing recommendations for antibiotics in sepsis treatment, enhancing patient outcomes.
How similar studies have performed: While there have been observations regarding hemoperfusion in sepsis, this specific evaluation of antibiotic clearance is novel and requires further clinical validation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Moscow and 3 other locations
- N. V. Sklifosovsky Moscow Research Institute of Emergency — Moscow, Russian Federation (Recruiting)
- N.I. Pirogov City Clinical Hospital No. 1 — Moscow, Russian Federation (Recruiting)
- Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko — Nizhny Novgorod, Russian Federation (Recruiting)
- Perm regional clinical hospital — Perm, Russian Federation (Recruiting)
Study contacts
- Principal investigator: Sergey Rey, PhD, MD — N. V. Sklifosovsky Moscow Research Institute of Emergency, Moscow, Russia
- Study coordinator: Alexandr Shelehov-Kravchenko, PhD, MD
- Email: alexandr.shelehov@gmail.com
- Phone: +0079636564765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.