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

Launched by SEASTAR MEDICAL · Feb 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called the Selective Cytopheretic Device (SCD) to see if it can help improve survival rates for patients with Acute Kidney Injury (AKI) who need continuous kidney replacement therapy (CKRT). The trial will include about 200 patients across 30 hospitals in the U.S., and participants will receive up to ten treatments with the SCD, each lasting 24 hours. The goal is to find out if this treatment not only helps patients live longer but also reduces the time they need to spend on dialysis due to AKI.

To be eligible for the study, patients must be at least 18 years old and no older than 80, currently in an intensive care unit (ICU) with AKI stage 2 or greater, and requiring CKRT for at least 12 but no more than 48 hours. They should also have another serious health issue. Patients who are not expected to survive the next 24 hours, have certain severe conditions, or are actively receiving treatment for advanced cancers may not be eligible. Participants can expect close monitoring and care throughout the trial, and they will be randomly assigned to either receive the SCD treatment or standard care. This trial is recruiting now, and it aims to provide important insights into better treatment options for patients with AKI.

Gender

ALL

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 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.