Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602245
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Clearance of Antibacterial Agents During Hemoperfusion in Patients With Sepsis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None