EAA-Guided AN69-oXiris and PMX-HP Therapy in Septic Patients

This is a prospective, randomized, open‐label, active‐comparator study evaluatingpatients who require intensive care for sepsis or septic shock related to anintra‐abdominal infection, including patients who have undergone emergency surgery oranother procedure for infection source control. After written informed consent andconfirmation of eligibility, participants will be randomized in a 1:1 ratio toAN69‐oXiris‐based blood purification or PMX‐HP. Because the devices and treatmentprocedures are visibly different, treatment allocation will not be blinded.In the AN69‐oXiris group, blood will be circulated through an AN69‐oXiris filter using anextracorporeal blood purification system during sequential treatment cycles over the72‐hour study period. In the PMX‐HP group, blood will be circulated through a polymyxinB‐immobilized cartridge for one or two hemoperfusion sessions, with the second sessionoccurring approximately 24 hours after treatment initiation when administered. Bothtreatments will be delivered through a central venous catheter with standard intensivecare monitoring. Standard treatment for sepsis and septic shock, including infectionsource control, antimicrobial therapy, hemodynamic support, organ support, and othertreatment considered necessary by the attending clinicians, will continue according toeach participant's clinical condition.Endotoxin activity will be assessed using the Endotoxin Activity Assay before and afterblood purification. Clinical and laboratory assessments will be performed at prespecifiedtime points from baseline through 72 hours. These assessments will include bloodpressure, vasopressor dose, lactate level, inflammatory markers, complete blood count,blood urea nitrogen and creatinine, C‐reactive protein, procalcitonin, arterial blood gasmeasurements, and measures of organ function. Additional clinical outcomes will includecomplications, intensive care unit and hospital length of stay, and mortality.The study will compare changes in endotoxin activity and clinical response between thetwo treatment groups and will examine whether baseline endotoxin activity and illnessseverity are associated with differential treatment response. The investigatorshypothesize that integrating endotoxin activity with short‐term physiologic andorgan‐function changes may help identify which blood purification strategy is moreappropriate for specific patients.Study treatment may be discontinued or modified if a participant's condition worsens orif the attending medical team determines that continued treatment is not appropriate.Necessary standard intensive care treatment will be maintained regardless ofdiscontinuation or modification of the assigned study treatment.