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:

• Must have AKI stage 2 or greater at the time of CKRT initiation.
• 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.