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Can blood purification turn the tide on sepsis?

NCT ID NCT07788144

Disease control Sponsor: Kyoung Moo Im Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial tests two blood purification treatments—AN69-oXiris and polymyxin B hemoperfusion—in intensive care patients with sepsis caused by abdominal infections. The goal is to see which method better reduces endotoxin, a bacterial toxin that fuels inflammation, and whether that improves survival and recovery. Fifty adults who had emergency surgery to control the infection will be randomly assigned to one of the two treatments, and their endotoxin levels and outcomes will be compared.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Two blood purification treatments: AN69-oXiris adsorptive hemofilter and polymyxin B hemoperfusion (PMX-HP)
What this could lead to
If one treatment proves better at lowering endotoxin, it could guide which blood purification method to use for sepsis patients, potentially improving survival and recovery.
What could go wrong
This is a small, early-stage study (50 participants) without a placebo group, so results may not apply broadly. Blood purification carries risks like bleeding, infection, or catheter complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants must meet all of the following criteria: 1. Adults aged 18 years or older. 2. Diagnosis of sepsis or septic shock caused by an intra-abdominal infection, including peritonitis, according to the Sepsis-3 criteria. 3. Completion of emergency surgery for infection source control, with successful surgical control of the infection source. 4. Admission to the surgical intensive care unit (SICU) for postoperative intensive care. 5. Ability to undergo measurement of endotoxin activity (EA) using the Endotoxin Activity Assay (EAA). 6. Determination by a critical care specialist that extracorporeal blood purification therapy with either AN69-oXiris or PMX-HP is clinically indicated. 7. Ability to obtain central venous access and undergo extracorporeal blood purification therapy. 8. Provision of voluntary written informed consent by the participant or the participant's legally authorized representative after receiving sufficient information about the study. Exclusion Criteria: * Participants meeting any of the following criteria will be excluded: 1. Younger than 18 years of age. 2. Surgical source control of the infection was not performed or was considered incomplete. 3. Pregnant or breastfeeding. 4. Refusal to participate in the study or inability to obtain informed consent from a legally authorized representative. 5. Concurrent participation in another clinical study.

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Conditions

The condition(s) this trial relates to.

infectious disease with sepsis Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endotoxin levels Hemoperfusion ICU Sepsis

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  3. A doctor treating you

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Contacts and locations

Locations

  • 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

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