None listed
Conditions
Interventions
Medical Device : Participants will be randomly assigned in a 1:1 ratio to either the AN69-oXiris group or the PMX-HP group. In the AN69-oXiris group, treatment will begin within 12 hours after success
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Adult patients aged 18 years or older ? Patients diagnosed with sepsis or septic shock caused by an intra-abdominal infection, such as peritonitis, according to the Sepsis-3 criteria ? Patients who have undergone emergency surgery for source control and in whom surgical source control has been successfully completed ? Patients admitted to the Surgical Intensive Care Unit (SICU) for postoperative intensive care ? Patients in whom endotoxin activity (EA) can be measured using the Endotoxin Activity Assay (EAA) ? Patients determined by an intensivist to require extracorporeal blood purification therapy with either AN69-oXiris or PMX-HP ? Patients in whom central venous access can be established and extracorporeal blood purification therapy can be performed ? Patients who, or whose legally authorized representatives, have received sufficient information about the study and voluntarily provided written informed consent
Exclusion criteria
Exclusion criteria: ? Pediatric patients under 18 years of age ? Patients in whom surgical source control is incomplete or has not been performed ? Pregnant or breastfeeding women ? Patients who refuse to participate in the study or for whom consent from a legally authorized representative cannot be obtained ? Patients concurrently participating in another clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| endotoxin activity | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Clinical outcome measures: 28-day mortality, length of ICU stay, total length of hospital stay, and incidence of postoperative complications.;(2) Hemodynamic parameters: Changes over time in the total Sequential Organ Failure Assessment (SOFA) score and cardiovascular SOFA subscore, and changes in vasopressor requirements assessed using the Vasoactive-Inotropic Score (VIS).;(3) Inflammatory markers: Changes over time in C-reactive protein (CRP), procalcitonin (PCT), presepsin, and lactate levels.;(4) Renal function parameters: Changes over time in blood urea nitrogen (BUN), serum creatinine, and urine output.;(5) Cost-effectiveness outcome: Analysis of treatment costs relative to survival. | — |
Countries
Korea, Republic of
Contacts
Public ContactKyoung Moo Im
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed