Selective Cytopheretic Device for Acute Kidney Injury
Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury
Recruiting
N/AInterventional Study
Acute Kidney Injury
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
339 (estimated)
Sponsor
SeaStar Medical · Industry
Who this trial is looking for
This trial is looking for patients with Acute Kidney Injury who are in the ICU and need continuous kidney treatment. Participants will receive additional treatment with a device to see if it helps improve survival and reduce the need for dialysis.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old but no older than 80.
I have Acute Kidney Injury stage 2 or greater.
I have been on continuous kidney replacement therapy for 12 to 48 hours.
I have another serious organ problem.
I have acceptable access for kidney treatment.
My C-Reactive Protein level is over 3.5 mg/dl.
I can commit to the current level of care for at least 96 hours.
You may not be able to join if
I am not expected to survive the next 24 hours.
I am transitioning to comfort care or hospice soon.
I have a terminal condition where I am not expected to survive 28 days.
I have advanced cancer that is actively being treated.
I have been in the ICU for more than 14 days during this hospital stay.
I have an active COVID-19 infection.
I have a history of chronic kidney disease stage greater than 3.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 re…
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.
Trial Locations
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Eligibility Criteria
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 e…
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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