Status:
COMPLETED
Clearance of Antibacterial Agents During Hemoperfusion in Patients With Sepsis
Lead Sponsor:
Efferon JSC
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
18-80 years
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 extracorpore...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 21 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 6 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06602245
Start Date
October 21 2024
End Date
April 6 2025
Last Update
December 2 2025
Active Locations (4)
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1
N. V. Sklifosovsky Moscow Research Institute of Emergency
Moscow, Russia
2
N.I. Pirogov City Clinical Hospital No. 1
Moscow, Russia
3
Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko
Nizhny Novgorod, Russia
4
Perm regional clinical hospital
Perm, Russia