Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury
Study Phase: N/A
Recruitment Status: Recruiting
Start Date: April 17, 2023
End Date: June 01, 2027
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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Conditions:
- Acute Kidney Injury
- Inflammation
- Kidney Cortex Necrosis