An interventional study of Selective Cytopheretic Device and Standard of Care in Acute Kidney Injury, sponsored by SeaStar Medical. Recruiting at 36 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by SeaStar Medical · Not applicable, Interventional, and Treatment
This randomized, controlled, pivotal study is intended to determine whether up to ten sequential 24-hour treatments with the Selective Cytopheretic Device (SCD) will improve survival in patients with Acute Kidney Injury (AKI) requiring continuous kidney replacement therapy (CKRT) when compared to CKRT alone (standard of care). This study is further intended to determine whether SCD therapy will reduce the duration of maintenance dialysis secondary to AKI. This study will enroll approximately 339 subjects across 30 US sites. Participants will be patients in an intensive care unit (ICU) setting with a diagnosis of AKI requiring CKRT.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's planned enrollment of 339 is above the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →SeaStar Medical is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Admitted to an ICU requiring CKRT:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In addition to standard of care CKRT therapy for these subjects, these subjects will have up to ten sequential 24-hour treatments with the Selective Cytopheretic Device (SCD) in-line with their existing CKRT circuit.
Device: Selective Cytopheretic Device
This arm will receive standard of care CKRT therapy for their condition as appropriate.
Other: Standard of Care
The Selective Cytopheretic Device (SCD) is comprised of tubing, connectors, and a synthetic hollow fiber membrane cartridge. The device is connected in series to a commercially available CKRT hemofilter. Blood from the CKRT circuit is diverted after the CKRT hemofilter through to the extracapillary space (ECS) of the SCD cartridge. Blood circulates through the SCD ECS and then it is returned to the patient via the venous return line of the CKRT circuit. Regional citrate anticoagulation is used for the entire CKRT and SCD blood circuit. The SCD cartridge incorporates a synthetic hollow fiber membrane with the ability to bind activated leukocytes to its extracapillary surface; and when used in a CKRT extracorporeal circuit in the presence of regional citrate anticoagulation, the SCD modulates inflammation.
Also known as: SCD
Standard of care CKRT for the subject's condition, as appropriate
Composite endpoint of mortality or dialysis dependency at 90 days
The composite of death or requiring kidney replacement therapy at 90 days post randomization
Time frame: 90 days
MAKE90
Major adverse kidney events at day 90 is a composite of death, need for KRT, or persistent renal dysfunction (final serum creatinine concentration, ≥200% of the baseline value) at the 90 day follow up period
Time frame: 90 days
Dialysis dependence
Need for any form of kidney replacement therapy at one year
Time frame: 1 year
ICU free days in the first 28 days
The number of days alive and requiring ICU level of care in the 28 days after randomization for at least 24 hours
Time frame: 28 days
Mortality at 28 days
Death by day 28 post randomization
Time frame: 28 days
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
SeaStar Medical