Clearance of Antibacterial Agents During Hemoperfusion in Patients With Sepsis

Launched by EFFERON JSC · Sep 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a specific treatment called hemoperfusion to see how well it can clear antibacterial drugs from the body in patients with sepsis, a serious infection that can lead to septic shock. This treatment aims to improve outcomes for patients who are critically ill due to sepsis, especially those whose infections may be caused by certain harmful bacteria. Researchers want to understand how effectively this method removes antibiotics, which are crucial for fighting infections.

To participate in this study, patients must weigh more than 40 kg (about 88 pounds) and have been diagnosed with sepsis or septic shock, believed to be caused by Gram-negative bacteria. However, some individuals won't be eligible, including pregnant or breastfeeding women, those who need other types of kidney treatments, or anyone who has a serious health condition that could complicate their participation. If eligible, participants can expect to receive the hemoperfusion treatment while being closely monitored by medical professionals to ensure their safety and well-being throughout the study.

Gender

ALL

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.