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Can blood filtration save kids with sepsis? new trial aims to find out

NCT ID NCT05595239

Disease control Sponsor: Children's Hospital of Fudan University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares three blood purification methods in 120 children with sepsis, aged 29 days to 18 years. The goal is to see which method best reduces inflammatory chemicals and organ damage. Researchers will also check survival rates at 28 days.

What this could mean

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

Active substance
blood purification (CVVH, TPE+CVVH, or HP+CVVH) using a device
What this could lead to
If successful, this could identify the best blood purification method to reduce harmful inflammation and improve survival in children with sepsis.
What could go wrong
This is an early-stage study with only 120 children, so results may not apply to all cases. The treatments are complex and carry risks like bleeding or infection.

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 120 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

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

29 days to 18 years

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: * Meet the 2005 diagnostic criteria for sepsis * Age 29 days - 18 years old * Sepsis-induced dysfunction of more than one organ or abnormal tissue perfusion, or septic shock * Diagnosis \< 48 hours Exclusion Criteria: * Inability to obtain an informed consent from the subject, family member or an authorized surrogate * Subject has end-stage renal disease and requires chronic dialysis * There is clinical support for non-septic shock * Subject has had chest compressions as part of cardiopulmonary resuscitation this hospitalization without immediate return to communicative state * Subject has uncontrolled hemorrhage * Subject has immunodeficiency diseases * Subject has received chemoradiotherapy or immunosuppressive therapy in the 14 days before enrollment * HIV infection in association with a last known or suspected CD4 count of \<50/mm3 * Subject has sustained extensive third-degree burns within the past 7 days * Subject has known sensitivity or allergy to heparin or has a history of heparin associated thrombocytopenia * Subject is currently enrolled in an investigational drug or device trial * Subject has been previously enrolled in the current trial * Any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate for enrollment, such as end stage chronic illness with no reasonable expectation of survival to hospital discharge * Known hypersensitivity to hemofilter * Subject has received organ transplantation * Subject is expected to die within 24 hours

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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.

Blood purification Sepsis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

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

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Lu Guoping

    Shanghai, Shanghai Municipality, 201102, China

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