New blood filter could save lives in septic shock
NCT ID NCT05011656
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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George Washington University
Washington D.C., District of Columbia, 20037, United States
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Good Samaritan Hospital
Corvallis, Oregon, 97330, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Methodist Hospital
San Antonio, Texas, 78229, United States
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Southeast Georgia Health System, Inc.
Brunswick, Georgia, 31520, United States
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Trinity Health Mid Atlantic-SMMC
Langhorne, Pennsylvania, 19047, United States
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University of Michigan
Ann Arbor, Michigan, 48109, United States
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University of Texas Health Science Center at San Antonio (UT Health San Antonio)
San Antonio, Texas, 78229, United States
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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.
- Bedside eye scans may reveal hidden blood flow problems in septic shock
- Can two blood markers catch sepsis before it turns deadly?
- Two cheap blood ratios put to the test as sepsis death predictors
- Can a bedside ultrasound predict which septic shock patients will stop breathing on their own?
- Can a computer model speed up sepsis blood tests?
- A routine calcium reading could reveal how sick a sepsis patient really is