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Study of the Selective Cytopheretic Device for Acute Kidney Injury

This study is testing a device called the Selective Cytopheretic Device (SCD) for people with acute kidney injury (AKI), which is when your kidneys suddenly stop working well. The SCD is a special filter that works with your existing continuous kidney replacement therapy (CKRT) machine. Researchers want to see if using the SCD for up to ten 24-hour treatments can help people with AKI survive longer or reduce how long they need dialysis, compared to just receiving standard CKRT. You could be eligible if you are in the intensive care unit (ICU), are 18-80 years old, have AKI stage 2 or greater, have been on CKRT for 12-48 hours, and have another life-threatening organ problem. The main goal is to see if the SCD can improve survival or reduce dialysis dependency 90 days after treatment. The current status of this study is unclear.

Study design
This is a randomized, controlled study, meaning participants will be randomly assigned to receive either the SCD with standard care or standard care alone. The study plans to enroll about 339 participants.
What's involved
You would receive up to ten 24-hour treatments with the Selective Cytopheretic Device or standard of care CKRT. These treatments would occur while you are in the ICU.
Compensation
Not stated in the trial record.
Follow-up
The study will track your health for 90 days to see if you are alive or still need dialysis.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05758077

Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury

Recruiting
NAAges 18+InterventionalTreatment
SeaStar Medical
~339 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:Selective Cytopheretic DeviceStandard of Care

At a glance

Recruiting sites
19 of 38 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite endpoint of mortality or dialysis dependency at 90 days
Measured over 90 days

Conditions

Acute Kidney Injury

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Where it's being run

38 sites across 20 states
Texas6
Pennsylvania4
California3
Florida3
Georgia3
Ohio3
Michigan2
Virginia2

Who to contact

Mohamed Zidan, MD
[email protected]
844-427-8100
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Admitted to an ICU requiring CKRT:
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

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.

What this trial measures

  • Composite endpoint of mortality or dialysis dependency at 90 days90 days

    The composite of death or requiring kidney replacement therapy at 90 days post randomization