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

NCT07788144 | Enrolling By Invitation DMC

• 1 other identifier: KC26DIST0386
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemoperfusion; Sepsis; ICU; Endotoxin Levels

Keywords

hemoperfusion; AN69-oXiris; PMX-HP; endotoxin

Outcome Measures

Primary Outcomes (1)

• Change in Endotoxin Activity Measured by the Endotoxin Activity Assay From Baseline Through 72 Hours

  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.

  Baseline (T0) and 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment

Secondary Outcomes (12)

• 28-day mortality rate

  Participants were followed up to 28 days immediately after the surgery

• Intensive Care Unit Length of Stay

  From intensive care unit admission to intensive care unit discharge or in-hospital death, assessed up to 180 days.

• Hospital Length of Stay

  From hospital admission until hospital discharge or in-hospital death, whichever occurs first, assessed up to 180 days.

• Incidence of Postoperative Complications

  From the index surgery through hospital discharge, assessed up to 180 days after surgery. For participants discharged before 180 days without postoperative complications, events occurring after hospital discharge will not be assessed.

• Change in Sequential Organ Failure Assessment (SOFA) Score From Baseline Through 72 Hours

  Baseline (T0) and 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment

Study Arms (2)

AN69-oXiris

EXPERIMENTAL

Participants assigned to this arm will receive extracorporeal blood purification using an AN69-oXiris hemofilter through a central venous catheter. Treatment will be administered in sequential cycles during the 72-hour study period, with filter replacement according to the study protocol and the participant's clinical condition. Standard treatment for sepsis or septic shock will continue as clinically indicated.

Device: Adsorptive Hemofilter for Continuous Renal Replacement Therapy

PMX-HP

EXPERIMENTAL

Participants assigned to this arm will receive direct hemoperfusion using a PMX-HP cartridge containing polymyxin B-immobilized fibers through a central venous catheter. Treatment will consist of one or two sessions. When a second session is administered, it will begin approximately 24 hours after initiation of the first session. Standard treatment for sepsis or septic shock will continue as clinically indicated.

Device: Polymyxin B-Immobilized Hemoperfusion Cartridge

Interventions

Adsorptive Hemofilter for Continuous Renal Replacement Therapy DEVICE

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.

Also known as: AN69-oXiris, oXiris

AN69-oXiris

Polymyxin B-Immobilized Hemoperfusion Cartridge DEVICE

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.

Also known as: PMX-HP, Toraymyxin

PMX-HP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria:
• Adults aged 18 years or older.
• Diagnosis of sepsis or septic shock caused by an intra-abdominal infection, including peritonitis, according to the Sepsis-3 criteria.
• Completion of emergency surgery for infection source control, with successful surgical control of the infection source.
• Admission to the surgical intensive care unit (SICU) for postoperative intensive care.
• Ability to undergo measurement of endotoxin activity (EA) using the Endotoxin Activity Assay (EAA).
• Determination by a critical care specialist that extracorporeal blood purification therapy with either AN69-oXiris or PMX-HP is clinically indicated.
• Ability to obtain central venous access and undergo extracorporeal blood purification therapy.
• Provision of voluntary written informed consent by the participant or the participant's legally authorized representative after receiving sufficient information about the study.

You may not qualify if:

• Participants meeting any of the following criteria will be excluded:
• Younger than 18 years of age.
• Surgical source control of the infection was not performed or was considered incomplete.
• Pregnant or breastfeeding.
• Refusal to participate in the study or inability to obtain informed consent from a legally authorized representative.
• Concurrent participation in another clinical study.

Sponsors & Collaborators

• Kyoung Moo Im: lead

Study Sites (1)

Division of Trauma and Surgical Critical Care, Department of Surgery, Seoul St. Mary's Hospital, Seoul, Seocho-gu, Banpo-dong banpodaero 222

Seoul, 137-701, South Korea

Location

Related Publications (3)

• Kim HS, Chung YJ, Lee GR, Kim EY. The clinical efficacy and suitable implementation of two extracorporeal blood purification therapies: AN69-oXiris versus PMX-HP. Front Med (Lausanne). 2024 Jan 31;11:1344893. doi: 10.3389/fmed.2024.1344893. eCollection 2024.

  PMID: 38357649 BACKGROUND

• Lee WY, Kim HJ, Kim EY. Impact of polymyxin B hemoperfusion therapy on high endotoxin activity level patients after successful infection source control: a prospective cohort study. Sci Rep. 2021 Dec 16;11(1):24132. doi: 10.1038/s41598-021-03055-8.

  PMID: 34916567 BACKGROUND

• Kim JJ, Park YJ, Moon KY, Park JH, Jeong YK, Kim EY. Polymyxin B hemoperfusion as a feasible therapy after source control in abdominal septic shock. World J Gastrointest Surg. 2019 Dec 27;11(12):422-432. doi: 10.4240/wjgs.v11.i12.422.

  PMID: 31879534 BACKGROUND

MeSH Terms

Conditions

Sepsis

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Kyoung Moo Im

  The Catholic University of Korea

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Fellow, Department of Critical Care and Trauma Surgery

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 26, 2026
• Study Start: August 11, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)