New device aims to save kidneys and lives in the ICU

NCT ID NCT05758077

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

First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This study tests a device called the Selective Cytopheretic Device (SCD) in 339 ICU patients with severe acute kidney injury who are already on continuous kidney replacement therapy. The device filters blood to reduce inflammation, and researchers want to see if it improves survival and reduces the need for long-term dialysis compared to standard care alone.

What this could mean

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

Active substance: Selective Cytopheretic Device (SCD) - a device that filters blood to reduce inflammation
What this could lead to: If successful, this device could help more people survive acute kidney injury and avoid long-term dialysis dependence.
What could go wrong: This is a pivotal trial but still experimental. The device adds complexity to standard care, and benefits may not outweigh risks like bleeding or infection.

Why investors are watching

SeaStar Medical is running a pivotal trial of its Selective Cytopheretic Device (SCD) in 339 ICU patients with acute kidney injury who need continuous kidney replacement therapy. The study tests whether up to ten 24-hour SCD treatments improve survival and reduce the need for ongoing dialysis compared to standard care alone. For a micro-cap company with this single device as its main focus, the readout will largely determine whether the product has a future.

If it works: A positive result could support regulatory approval and give SeaStar its first commercial product. That would validate the technology and open a path to revenue in a large patient population.

If it fails: A failed or delayed trial could leave the company without a viable product and with limited resources to continue. Trials in critically ill patients often fail, and the outcome is uncertain.

AI-written from the trial record. Speculative, and not investment advice.

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 339 people

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

Started

Apr 2023

Expected to finish

Jun 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: * Admitted to an ICU requiring CKRT: 1. Must have AKI stage 2 or greater at the time of CKRT initiation. 2. Must have been on CKRT for at least 12 hours but no greater than 48 hours at the time of enrollment. * At least 18 years of age but not older than 80 at the time of enrollment. * One additional life-threatening organ dysfunction present. * Acceptable vascular access for CKRT to include adequate lumen size and length of catheters. * Initial (non-binding) commitment to maintaining current level of care for at least 96 hours. * C-Reactive Protein \>3.5 mg/dl. Exclusion Criteria: * Not expected to survive next 24 hours. * Anticipated transition to comfort measures or hospice in next 4 days. * Terminal condition whereby the patient is not expected to survive 28 days or any condition in which therapy is regarded as futile by the PI. * Advanced malignancy which is actively being treated or may be treated with palliative chemotherapy or radiation. * ICU hospitalization \> 14 days during this hospital admission (to include days spent at ICU of an outside hospital) at the time of screening. * Active COVID-19 infection with a primary admission diagnosis of COVID-19. * Chronic use of ventricular assist devices. * ESRD requiring chronic kidney replacement therapy. * History of CKD (greater than Stage 3). * AKI stage 0 or stage 1 at the time of CKRT initiation. * Non-ATN AKI diagnosis. We intend on relying on local nephrology subspecialty expertise to reasonably exclude non-ATN diagnoses based on clinical suspicions combined with prespecified objective criteria. If there is a reasonable suspicion that the subject has non-ATN AKI based on this, they will be excluded from the trial. * Acute coronary syndromes, acute stroke, or acute major vascular compromise requiring medical or surgical interventions within 48 hours of randomization. * Active hemorrhage requiring blood transfusions at the time of screening. * Acute on Chronic Liver Failure. * Suspicion of hepato-renal syndrome. * Presence of any solid organ transplant at any time prior to admission. * Severe burns with a modified Baux score \> 100 (%TBSA+Age+17 for Inhalation Injury). * Bone marrow transplant within the last year. * Chronic immunosuppression with an average of \>20 mg/day of prednisone or other steroid sparing immunosuppressants for the past 30 days prior to hospital admission. * Individuals who have a history of primary or secondary immune disorders including, but not limited to, HIV or AIDS. * Dry weight of \>150kg. * Platelet count \<15,000/mm3. * Patient is a prisoner or member of a vulnerable population. * Patient is pregnant or breast feeding. * Concurrent enrollment in another interventional clinical trial for an investigational drug or device. * Need for plasmapheresis.

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Conditions

The condition(s) this trial relates to.

acute kidney injury Inflammation kidney cortex necrosis

As listed by the trial registrant

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

Acute kidney injury

How to take part

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

The places running it

32 sites. The list below names each one and where it is.
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 ↗
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

AdventHealth Orlando
RECRUITING

Orlando, Florida, 32803, United States
Brooke Army Medical Center
RECRUITING

Fort Sam Houston, Texas, 78234, United States
Cleveland Clinic
RECRUITING

Cleveland, Ohio, 44195, United States
Emory Healthcare
RECRUITING

Atlanta, Georgia, 30322, United States
Henry Ford Medical Center
RECRUITING

Detroit, Michigan, 48202, United States
JMS Burn Center
WITHDRAWN

Augusta, Georgia, 30909, United States
Keck Hospital of USC
NOT_YET_RECRUITING

Los Angeles, California, 90033, United States
Mayo Clinic
RECRUITING

Rochester, Minnesota, 55902, United States
Mayo Clinic in Arizona
NOT_YET_RECRUITING

Phoenix, Arizona, 85054, United States
Mayo Clinic in Florida
NOT_YET_RECRUITING

Jacksonville, Florida, 32224, United States
Medical University of South Carolina
NOT_YET_RECRUITING

Charleston, South Carolina, 29425, United States
Methodist Hospital
RECRUITING

San Antonio, Texas, 78229, United States
Methodist Hospital Metropolitan
RECRUITING

San Antonio, Texas, 78212, United States
Northeast Georgia Health System
NOT_YET_RECRUITING

Gainesville, Georgia, 30501, United States
Ochsner LSU Health Academic Medical Center
RECRUITING

Shreveport, Louisiana, 71103, United States
Ronald Reagan UCLA Medical Center
RECRUITING

Los Angeles, California, 90095, United States
Saint Mary Medical Center
RECRUITING

Langhorne, Pennsylvania, 19047, United States
Samaritan Health
ACTIVE_NOT_RECRUITING

Corvallis, Oregon, 97330, United States
Sentara Health
RECRUITING

Norfolk, Virginia, 23507, United States
St Luke's University Hospital
RECRUITING

Bethlehem, Pennsylvania, 19015, United States
Stanford University
RECRUITING

Palo Alto, California, 94304, United States
Stony Brook University Hospital
NOT_YET_RECRUITING

Stony Brook, New York, 11794, United States
The Mount Sinai Hospital
NOT_YET_RECRUITING

New York, New York, 10029, United States
The Ohio State University Wexner Medical Center
NOT_YET_RECRUITING

Columbus, Ohio, 43210, United States
United States Army Institute of Surgical Research
WITHDRAWN

JBSA Fort Sam Houston, Texas, 78234, United States
University of Alabama Birmingham Hospital
RECRUITING

Birmingham, Alabama, 35233, United States
University of California San Francisco
RECRUITING

San Francisco, California, 94143, United States
University of Cincinnati
RECRUITING

Cincinnati, Ohio, 45219, United States
University of Colorado Hospital Anschutz Medical Campus
WITHDRAWN

Aurora, Colorado, 80045, United States
University of Iowa Hospital
RECRUITING

Iowa City, Iowa, 52242, United States
University of Kentucky HealthCare
NOT_YET_RECRUITING

Lexington, Kentucky, 40536, United States
University of Maryland Medical Center
NOT_YET_RECRUITING

Baltimore, Maryland, 21201, United States
University of Michigan
RECRUITING

Ann Arbor, Michigan, 48109, United States
University of North Carolina
NOT_YET_RECRUITING

Chapel Hill, North Carolina, 27599, United States
University of Texas Health San Antonio
RECRUITING

San Antonio, Texas, 78229, United States
University of Texas Southwestern Medical Center
RECRUITING

Dallas, Texas, 75390, United States

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