Early post-approval experience of the selective cytopheretic device surveillance registry for pediatric AKI requiring kidney replacement therapy

Abstract

Background: The selective cytopheretic device for pediatrics (SCD-PED) was granted a Humanitarian Device Exemption (HDE) in 2024 by United States Food and Drug Administration (FDA) for treatment of critically ill children weighing ≥ 10 kg with AKI due to sepsis or a septic condition on antibiotics and requiring continuous kidney replacement therapy (CKRT). FDA required a post-approval surveillance registry to collect additional safety data among all patients treated with SCD-PED under the HDE as part of the approval. Methods: The SCD-PED PediAtric SurVeillance REgistry (SAVE; NCT06517810) was initially planned to enroll 300 patients under the HDE-approved indication, but the target was later reduced to 50. The primary outcome is a new (secondary) blood stream infection in the first 28 days after SCD-PED initiation. Additional Day 28 and Day 90 clinical outcomes including mortality and KRT requirement will be collected. Results: Registry design and preliminary outcomes from the first 21 patients are reported. Three new positive blood cultures were observed during the follow-up period after cessation of SCD-PED therapy, all of which were deemed unrelated to SCD. Sixteen (76%) and 15 (71%) of 21 patients survived through to Days 60 and 90, respectively. Three patients died while receiving SCD-PED therapy. No device-related adverse events were reported. Conclusion: This initial real-world experience of SCD-PED therapy in pediatric AKI with sepsis in patients requiring CKRT suggests no device-related infections and similar improved clinical outcomes consistent with the previous trial SCD-PED experience in this critically ill population.