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New blood filter could save lives in septic shock

NCT ID NCT05011656

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a new blood filtering therapy for adults in the ICU with septic shock, a life-threatening condition caused by severe infection. The treatment aims to remove harmful substances from the blood to help patients recover faster. The trial includes 15 participants and focuses on safety and early signs of 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.

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 15 people

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

Started

Apr 2024

Expected to finish

Jul 2027

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.

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: 1. Admitted to an ICU with pathogen associated shock defined as: * The need for vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mmHg despite adequate fluid resuscitation, AND * Presence of a pathogen detected in the bloodstream within 72 hours of screening using commercially available in-vitro diagnostic testing 2. Male or non-pregnant female adult 3. At least 18 years of age at time of enrollment Exclusion Criteria: 1. Pregnant or breast feeding 2. Anticipated transfer to another hospital (that is not a study site) within 72 hours for any reason 3. Not anticipated to survive more than 24 hours 4. Known allergy to heparin sodium 5. Patients who cannot tolerate placement of double-lumen catheter 6. High risk of bleeding (platelet count \<50mm3 or International Normalized Ratio (INR) \>2) unless adequate line for treatment already placed (e.g. ECMO or RRT/CRRT) 7. Inability to tolerate extracorporeal therapy (defined as MAP\<65 despite fluids and vasopressors) 8. Advanced cancer (defined as stage IV) with life expectancy of less than 30 days 9. Unable to obtain informed consent from either patient or legally authorized representative (LAR) 10. Hypotension and volume depletion due to etiologies other than sepsis. 11. Neutropenia with an absolute neutrophil count \<500mm3 12. Patients must be treated with one of the antimicrobial agents listed in the Antimicrobial Management Guideline (Table 19). Patients who require treatment with an antimicrobial outside of this list while still receiving treatment with the investigational device must be excluded from the study. 13. If a patient enters the study and later requires a change in the antimicrobial agent used to one which is not listed in the Antimicrobial Management Guideline while still receiving treatment with the investigational device, that patient must be removed from this trial. Clinical data for any patient removed from the trial for this reason will continue to be collected for safety evaluation". 14. Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator or IRB/ethics committee. 15. Advanced directive for "Do Not Resuscitate".

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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.

Contacts and locations

Locations

  • George Washington University

    Washington D.C., District of Columbia, 20037, United States

  • Good Samaritan Hospital

    Corvallis, Oregon, 97330, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Methodist Hospital

    San Antonio, Texas, 78229, United States

  • Southeast Georgia Health System, Inc.

    Brunswick, Georgia, 31520, United States

  • Trinity Health Mid Atlantic-SMMC

    Langhorne, Pennsylvania, 19047, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Texas Health Science Center at San Antonio (UT Health San Antonio)

    San Antonio, Texas, 78229, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

More trials for these conditions

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