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

Condition(s) studied

Investigational drug(s) / intervention(s)

Adsorptive Hemofilter for Continuous Renal Replacement Therapy: Participants assigned to the AN69-oXiris group will receive extracorporeal blood purification using an AN69-oXiris adsorptive hemofilter connected to a Prismaflex continuous renal replacement therapy system. Vascular access will be obtained using a 12-Fr dual-lumen catheter inserted into the internal jugular or femoral vein. Treatment will begin within 12 hours after successful surgical source control. One filter will be used per session for three consecutive 24-hour sessions, with a maximum treatment duration of 72 hours. The blood flow rate will be 100-150 mL/min, the replacement fluid rate will be 150-900 mL/hour, and the dialysate flow rate will be 700-1,200 mL/hour. Treatment settings may be adjusted according to the participant's clinical condition. Standard treatment for sepsis and septic shock will be provided concurrently.

Polymyxin B-Immobilized Hemoperfusion Cartridge: Participants assigned to the PMX-HP group will receive direct hemoperfusion using a PMX-20R cartridge containing polymyxin B-immobilized fibers connected to a Prismaflex extracorporeal circulation system. Vascular access will be obtained using a 12-Fr central venous catheter inserted into the internal jugular or femoral vein. The first session will begin within 12 hours after successful surgical source control, and the second session will be performed within 24 hours after completion of the first session. One cartridge will be used per session for a total of two 6-hour sessions. The blood flow rate will be 80-120 mL/min and may be adjusted according to the participant's clinical condition. Treatment may be discontinued early if clinically necessary. Standard treatment for sepsis and septic shock will be provided concurrently.

Study summary

Sepsis and septic shock are life-threatening conditions in which the body's response to infection can cause dangerously low blood pressure and organ failure. In some patients with an infection inside the abdomen, severe inflammation may continue even after emergency surgery or another procedure has controlled the source of infection. Endotoxin is a substance produced by certain bacteria that may worsen this inflammation. The Endotoxin Activity Assay is a blood test that estimates how strongly endotoxin is affecting the body.

This study will compare two blood purification treatments, AN69-oXiris and polymyxin B hemoperfusion (PMX-HP), in patients receiving intensive care for sepsis or septic shock caused by an intra-abdominal infection. Blood purification removes blood through a central venous catheter, passes it through a special filter or cartridge, and then returns it to the body. These treatments are intended to reduce endotoxin or other substances involved in inflammation.

The study plans to enroll 50 participants at Seoul St. Mary's Hospital. Participants will be assigned by chance, in a 1:1 ratio, to receive either AN69-oXiris or PMX-HP. Participants and the clinical team will know which treatment is used.

Eligibility

Primary outcome measure(s)

• Change in Endotoxin Activity Measured by the Endotoxin Activity Assay From Baseline Through 72 Hours — Baseline (T0) and 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment
  Endotoxin activity (EA) will be measured using the Endotoxin Activity Assay (EAA) at baseline (T0) and at 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment. Higher EA values indicate greater endotoxin activity. For each post-baseline time point, the change from baseline will be calculated as the EA value at T1, T2, or T3 minus the EA value at T0. A negative change indicates a reduction in endotoxin activity. Changes in EA values over time will be compared between the AN69-oXiris and PMX-HP groups.

Trial sites (1)

Other trials for the same condition