HemoperfusionNCT07788144
EAA-Guided AN69-oXiris and PMX-HP Therapy in Septic Patients
A study testing Adsorptive Hemofilter for Continuous Renal Replacement Therapy and Polymyxin B-Immobilized Hemoperfusion Cartridge in people with Hemoperfusion and Sepsis, run by Kyoung Moo Im at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemoperfusion, Sepsis, ICU
- What is being tested?
- Adsorptive Hemofilter for Continuous Renal Replacement Therapy and Polymyxin B-Immobilized Hemoperfusion Cartridge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Aug 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
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
About this study
Official title: Establishing Evidence Based Application of AN69-oXiris and PMX-HP Therapies Based on the Endotoxin Activity Assay in Septic Patients
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.
Read the detailed description
This is a prospective, randomized, open-label, active-comparator study evaluating patients who require intensive care for sepsis or septic shock related to an intra-abdominal infection, including patients who have undergone emergency surgery or another procedure for infection source control. After written informed consent and confirmation of eligibility, participants will be randomized in a 1:1 ratio to AN69-oXiris-based blood purification or PMX-HP. Because the devices and treatment procedures are visibly different, treatment allocation will not be blinded.
In the AN69-oXiris group, blood will be circulated through an AN69-oXiris filter using an extracorporeal blood purification system during sequential treatment cycles over the 72-hour study period. In the PMX-HP group, blood will be circulated through a polymyxin B-immobilized cartridge for one or two hemoperfusion sessions, with the second session occurring approximately 24 hours after treatment initiation when administered. Both treatments will be delivered through a central venous catheter with standard intensive care monitoring. Standard treatment for sepsis and septic shock, including infection source control, antimicrobial therapy, hemodynamic support, organ support, and other treatment considered necessary by the attending clinicians, will continue according to each participant's clinical condition.
Endotoxin activity will be assessed using the Endotoxin Activity Assay before and after blood purification. Clinical and laboratory assessments will be performed at prespecified time points from baseline through 72 hours. These assessments will include blood pressure, vasopressor dose, lactate level, inflammatory markers, complete blood count, blood urea nitrogen and creatinine, C-reactive protein, procalcitonin, arterial blood gas measurements, and measures of organ function. Additional clinical outcomes will include complications, intensive care unit and hospital length of stay, and mortality.
The study will compare changes in endotoxin activity and clinical response between the two treatment groups and will examine whether baseline endotoxin activity and illness severity are associated with differential treatment response. The investigators hypothesize that integrating endotoxin activity with short-term physiologic and organ-function changes may help identify which blood purification strategy is more appropriate for specific patients.
Study treatment may be discontinued or modified if a participant's condition worsens or if the attending medical team determines that continued treatment is not appropriate. Necessary standard intensive care treatment will be maintained regardless of discontinuation or modification of the assigned study treatment.
- Conditions
- Hemoperfusion, Sepsis, ICU, Endotoxin Levels
- Being tested
- Adsorptive Hemofilter for Continuous Renal Replacement Therapy, Polymyxin B-Immobilized Hemoperfusion Cartridge
- Keywords
- hemoperfusion, AN69-oXiris, PMX-HP, endotoxin
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adsorptive Hemofilter for Continuous Renal Replacement TherapyDevice
Also called AN69-oXiris, oXiris
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 CartridgeDevice
Also called PMX-HP, Toraymyxin
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Polymyxin B-Immobilized Hemoperfusion Cartridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Proportion of patients who died within 28 days after surgery among participants
Measured: Participants were followed up to 28 days immediately after the surgery
Intensive Care Unit Length of Stay
Intensive care unit length of stay will be calculated as the number of days from intensive care unit admission to intensive care unit discharge. Participants who die before intensive care unit discharge will be accounted for according to the prespecified statistical analysis plan. The outcome will be compared between the two treatment groups.
Measured: From intensive care unit admission to intensive care unit discharge or in-hospital death, assessed up to 180 days.
Hospital Length of Stay
Hospital length of stay will be calculated as the number of days from hospital admission to hospital discharge. Participants who die before hospital discharge will be accounted for according to the prespecified statistical analysis plan. The outcome will be compared between the two treatment groups.
Measured: From hospital admission until hospital discharge or in-hospital death, whichever occurs first, assessed up to 180 days.
Incidence of Postoperative Complications
The proportion of participants who experience one or more protocol-defined postoperative complications following the index surgery will be assessed. Complications will be identified from medical records and investigator assessments and compared between the AN69-oXiris and PMX-HP groups.
Measured: 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
The SOFA score assesses dysfunction in six organ systems: respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal. The total score ranges from 0 to 24, with higher scores indicating more severe organ dysfunction. Change from baseline will be calculated as the score at T1, T2, or T3 minus the score at T0. A negative change indicates improvement. Changes over time will be compared between the two treatment groups.
Measured: Baseline (T0) and 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment
Treatment Cost per Participant Alive at Day 28
Direct costs attributable to the assigned blood purification treatment, including the costs of filters or cartridges and treatment-related consumable supplies, will be calculated in Korean won. Treatment costs will be analyzed in relation to survival status at Day 28. Cost-effectiveness will be expressed as the treatment cost per participant alive at Day 28 and compared between the AN69-oXiris and PMX-HP groups according to the prespecified analysis plan.
Measured: Treatment costs accrued from treatment initiation through completion of the assigned treatment, with survival assessed at Day 28
Change in C-Reactive Protein From Baseline Through 72 Hours
C-reactive protein (CRP) will be measured at baseline (T0) and at 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment. Change from baseline at each post-treatment time point will be calculated as the CRP value at T1, T2, or T3 minus the value at T0. Changes over time will be compared between the AN69-oXiris and PMX-HP groups.
Unit of Measure: mg/L
Measured: Baseline (T0) and 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment
Change in Procalcitonin From Baseline Through 72 Hours
Procalcitonin (PCT) will be measured at baseline (T0) and at 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment. Change from baseline at each post-treatment time point will be calculated as the PCT value at T1, T2, or T3 minus the value at T0. Changes over time will be compared between the AN69-oXiris and PMX-HP groups.
Unit of Measure: ng/mL
Measured: Baseline (T0) and 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment
Change in Presepsin From Baseline Through 72 Hours
Presepsin will be measured at baseline (T0) and at 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment. Change from baseline at each post-treatment time point will be calculated as the presepsin value at T1, T2, or T3 minus the value at T0. Changes over time will be compared between the AN69-oXiris and PMX-HP groups.
Unit of Measure: pg/mL
Measured: Baseline (T0) and 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment
Change in Lactate From Baseline Through 72 Hours
Blood lactate will be measured at baseline (T0) and at 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment. Change from baseline at each post-treatment time point will be calculated as the lactate value at T1, T2, or T3 minus the value at T0. Changes over time will be compared between the AN69-oXiris and PMX-HP groups.
Unit of Measure: mmol/L
Measured: Baseline (T0) and 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment
Change in Blood Urea Nitrogen and Serum Creatinine From Baseline Through 72 Hours
Blood urea nitrogen (BUN) and serum creatinine(Cr) will be measured at baseline (T0) and at 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment. Change from baseline at each post-treatment time point will be calculated as the BUN and Cr value at T1, T2, or T3 minus the value at T0. Changes over time will be compared between the AN69-oXiris and PMX-HP groups.
Unit of Measure: mg/dL
Measured: Baseline (T0) and 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment
Weight-Normalized Urine Output Through 72 Hours
Urine output will be recorded during the protocol-defined assessment intervals and normalized by body weight. Weight-normalized urine output will be compared between the AN69-oXiris and PMX-HP groups at each assessment interval.
Unit of Measure: mL/kg/hour
Measured: Baseline (T0) and 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start11 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HemoperfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyoung Moo Im
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kyoung Moo Im, Seoul St. Mary's Hospital
- Investigators
- Kyoung Moo Im, Study director, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788144
- Sponsor's protocol ID
- KC26DIST0386
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no IPD-sharing plan or data-sharing consent has been established for this study. Study data will be managed and used in accordance with the IRB-approved protocol and informed consent form.
Publications
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.
PubMed 38357649Lee 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.
PubMed 34916567Kim 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.
PubMed 31879534
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Evidence Based Application of AN69-oXiris and PMX-HP Therapies Based on the Endotoxin Activity Assay in Septic Patients
- ClinicalTrials.gov ID
- NCT07788144
- Acronym / sponsor ID
- KC26DIST0386
- Conditions
- Hemoperfusion, Sepsis, ICU, Endotoxin Levels
- Keywords
- hemoperfusion, AN69-oXiris, PMX-HP, endotoxin
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kyoung Moo ImUniversity, hospital or other
- Study start
- 11 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, randomized, open-label, active-comparator study evaluating patients who require intensive care for sepsis or septic shock related to an intra-abdominal infection, including patients who have undergone emergency surgery or another procedure for infection source control. After written informed consent and confirmation of eligibility, participants will be randomized in a 1:1 ratio to AN69-oXiris-based blood purification or PMX-HP. Because the devices and treatment procedures are visibly different, treatment allocation will not be blinded.
In the AN69-oXiris group, blood will be circulated through an AN69-oXiris filter using an extracorporeal blood purification system during sequential treatment cycles over the 72-hour study period. In the PMX-HP group, blood will be circulated through a polymyxin B-immobilized cartridge for one or two hemoperfusion sessions, with the second session occurring approximately 24 hours after treatment initiation when administered. Both treatments will be delivered through a central venous catheter with standard intensive care monitoring. Standard treatment for sepsis and septic shock, including infection source control, antimicrobial therapy, hemodynamic support, organ support, and other treatment considered necessary by the attending clinicians, will continue according to each participant's clinical condition.
Endotoxin activity will be assessed using the Endotoxin Activity Assay before and after blood purification. Clinical and laboratory assessments will be performed at prespecified time points from baseline through 72 hours. These assessments will include blood pressure, vasopressor dose, lactate level, inflammatory markers, complete blood count, blood urea nitrogen and creatinine, C-reactive protein, procalcitonin, arterial blood gas measurements, and measures of organ function. Additional clinical outcomes will include complications, intensive care unit and hospital length of stay, and mortality.
The study will compare changes in endotoxin activity and clinical response between the two treatment groups and will examine whether baseline endotoxin activity and illness severity are associated with differential treatment response. The investigators hypothesize that integrating endotoxin activity with short-term physiologic and organ-function changes may help identify which blood purification strategy is more appropriate for specific patients.
Study treatment may be discontinued or modified if a participant's condition worsens or if the attending medical team determines that continued treatment is not appropriate. Necessary standard intensive care treatment will be maintained regardless of discontinuation or modification of the assigned study treatment.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AN69-oXiris | Experimental | Device: Adsorptive Hemofilter for Continuous Renal Replacement TherapyParticipants 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. |
| PMX-HP | Experimental | Device: Polymyxin B-Immobilized Hemoperfusion CartridgeParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants must meet all of the following criteria:
Key exclusion criteria (6 listed)
- Participants meeting any of the following criteria will be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adsorptive Hemofilter for Continuous Renal Replacement TherapyAlso: AN69-oXiris, oXirisParticipants 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. | Device | AN69-oXiris |
| Polymyxin B-Immobilized Hemoperfusion CartridgeAlso: PMX-HP, ToraymyxinParticipants 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. | Device | PMX-HP |
Primary outcome
Change in Endotoxin Activity Measured by the Endotoxin Activity Assay From Baseline Through 72 Hours
Time frame: 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.
12 secondary outcomes
28-day mortality rate
Time frame: Participants were followed up to 28 days immediately after the surgery
Intensive Care Unit Length of Stay
Time frame: From intensive care unit admission to intensive care unit discharge or in-hospital death, assessed up to 180 days.
Hospital Length of Stay
Time frame: From hospital admission until hospital discharge or in-hospital death, whichever occurs first, assessed up to 180 days.
Incidence of Postoperative Complications
Time frame: 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
Time frame: Baseline (T0) and 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment
Treatment Cost per Participant Alive at Day 28
Time frame: Treatment costs accrued from treatment initiation through completion of the assigned treatment, with survival assessed at Day 28
Change in C-Reactive Protein From Baseline Through 72 Hours
Time frame: Baseline (T0) and 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment
Change in Procalcitonin From Baseline Through 72 Hours
Time frame: Baseline (T0) and 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment
Change in Presepsin From Baseline Through 72 Hours
Time frame: Baseline (T0) and 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment
Change in Lactate From Baseline Through 72 Hours
Time frame: Baseline (T0) and 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment
Change in Blood Urea Nitrogen and Serum Creatinine From Baseline Through 72 Hours
Time frame: Baseline (T0) and 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment
Weight-Normalized Urine Output Through 72 Hours
Time frame: Baseline (T0) and 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 38357649Kim 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.
- Background: PubMed 34916567Lee 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.
- Background: PubMed 31879534Kim 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no IPD-sharing plan or data-sharing consent has been established for this study. Study data will be managed and used in accordance with the IRB-approved protocol and informed consent form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyoung Moo Im study director
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adsorptive Hemofilter for Continuous Renal Replacement Therapy and Polymyxin B-Immobilized Hemoperfusion Cartridge in people with Hemoperfusion and Sepsis, run by Kyoung Moo Im at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Endotoxin Activity Measured by the Endotoxin Activity Assay From Baseline Through 72 Hours (time frame: Baseline (T0) and 24 hours (T1), 48 hours (T2), and 72 hours (T3) after initiation of the assigned treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07788144, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.