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New device for kids with kidney failure under safety watch

NCT ID NCT06517810

Disease control Sponsor: SeaStar Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study monitors the safety of QUELIMMUNE, a device already approved for emergency use in critically ill children with acute kidney injury caused by sepsis. Researchers will track 50 patients to see how many develop new bloodstream infections within 28 days. The goal is to ensure the device is safe when used in real-world hospital settings.

What this could mean

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

Active substance
QUELIMMUNE (SCD-PED) device
What this could lead to
If successful, this registry could confirm that QUELIMMUNE is safe for routine use in critically ill children with kidney injury from sepsis.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove the device works better than standard care. The main focus is safety, not effectiveness.

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.

Participants

About 50 people

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

Started

Jul 2024

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Pediatric patients (weight ≥10kg and age ≤22 years) with acute kidney injury (AKI) due to sepsis or a septic condition on antibiotic therapy and requiring renal replacement therapy (RRT), per device Instructions For Use. All patients who receive treatment with QUELIMMUNE as part of their therapy are included in this registry.

Ages

Up to 22 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: * All patients initiated on QUELIMMUNE therapy under the HDE-approved indication Exclusion Criteria: * Weight \<10kg * Age \>22 years * Known allergy to any components of QUELIMMUNE

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Conditions

The condition(s) this trial relates to.

acute kidney injury Inflammation

As listed by the trial registrant

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

Acute kidney injury Acute kidney injury due to sepsis

How to take part

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

  1. The places running it

    15 sites. 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

  • CS Mott Children's Hospital

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Children's Hospital of Atlanta - Arthur M. Blank

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Children's Hospital of Atlanta - Scottish Rite

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Medical Center Dallas

    RECRUITING

    Dallas, Texas, 75235, United States

  • Children's of Alabama

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • Cincinnati Children's Hospital

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Cleveland Clinic Children's Hospital

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Cook Children's Hospital

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • HealthONE HCA Rocky Mountain Children's Hospital

    RECRUITING

    Denver, Colorado, 80205, United States

  • Lucile Packard Children's Hospital Stanford

    RECRUITING

    Palo Alto, California, 94304, United States

  • Lurie Children's Hospital of Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Monroe Carrell Jr Children's Hospital at Vanderbilt

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Texas Children's Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • UCSF Benioff Children's

    RECRUITING

    San Francisco, California, 94618, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.