Can a blood filter strip away toxins in septic shock?

NCT ID NCT07807410

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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Paused for now. It may or may not start again.
Ongoing
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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 Results may not be published yet.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.
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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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

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First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This trial tests whether a special filter called oXiris, used during continuous blood purification, can lower endotoxin levels in adults with septic shock and acute kidney injury. Septic shock is a life-threatening condition where infection causes severe organ failure. The filter aims to remove endotoxin and inflammatory substances from the blood while supporting the kidneys. About 13 participants will receive 24 hours of treatment with the oXiris filter, and researchers will measure changes in blood endotoxin, inflammation, organ function, and survival over 90 days.

What this could mean

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

Active substance
oXiris hemofilter, a blood-filtering device used during continuous renal replacement therapy to remove endotoxin and inflammatory substances
What this could lead to
If it works, this filter could reduce harmful toxins in the blood during septic shock, potentially improving organ function and survival in critically ill patients.
What could go wrong
This is a small, single-arm study with no comparison group, so results may not be conclusive. The filter may not lower endotoxin enough to change outcomes, and risks include clotting or complications from the dialysis procedure.

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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 13 people

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

Started

Aug 2026

Expected to finish

Aug 2027

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: * Age 18 years or older. * Diagnosis of septic shock according to Sepsis-3 criteria: sepsis with persistent hypotension requiring vasopressors to maintain a mean arterial pressure of at least 65 mmHg and a blood lactate level greater than 2 mmol/L despite adequate fluid resuscitation. * Acute kidney injury classified as KDIGO stage 2 or 3. * A clinical decision by the treating team to initiate continuous renal replacement therapy (CRRT). Exclusion Criteria: * The decision to initiate CRRT was made 24 hours or more before enrollment. * A documented decision to limit life-sustaining treatment or not to pursue invasive treatment. * Active major bleeding, a major bleeding event within the previous 48 hours, or severe uncorrected bleeding tendency. * Confirmed or suspected heparin-induced thrombocytopenia, or a known severe allergy to heparin or the filter materials. * Severe irreversible end-stage organ failure with an expected survival of 48 hours or less. * Pregnancy or breastfeeding. * Participation within the previous 6 months in another interventional study that may affect the outcomes of this study. * Written informed consent not obtained from the participant or legally authorized representative.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  2. The official record

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Contacts and locations

Locations

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510120, China

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