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

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 atthe 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 ofcatheters.

• 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 anycondition in which therapy is regarded as futile by the PI.

• Advanced malignancy which is actively being treated or may be treated withpalliative chemotherapy or radiation.

• ICU hospitalization > 14 days during this hospital admission (to include days spentat 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 subspecialtyexpertise to reasonably exclude non-ATN diagnoses based on clinical suspicionscombined with prespecified objective criteria. If there is a reasonable suspicionthat the subject has non-ATN AKI based on this, they will be excluded from thetrial.

• Acute coronary syndromes, acute stroke, or acute major vascular compromise requiringmedical 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 othersteroid 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 aninvestigational drug or device.

• Need for plasmapheresis.