{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T23:34:38Z","timestamp":1784158478119,"version":"3.55.0"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"7","license":[{"start":{"date-parts":[[2026,2,6]],"date-time":"2026-02-06T00:00:00Z","timestamp":1770336000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,2,6]],"date-time":"2026-02-06T00:00:00Z","timestamp":1770336000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Pediatr Nephrol"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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\u2009\u2265\u200910\u00a0kg 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      The\n                      <jats:italic>S<\/jats:italic>\n                      CD-PED Pedi\n                      <jats:italic>A<\/jats:italic>\n                      tric Sur\n                      <jats:italic>V<\/jats:italic>\n                      eillance R\n                      <jats:italic>E<\/jats:italic>\n                      gistry (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\u00a0days after SCD-PED initiation. Additional Day 28 and Day 90 clinical outcomes including mortality and KRT requirement will be collected.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00467-026-07181-1","type":"journal-article","created":{"date-parts":[[2026,2,6]],"date-time":"2026-02-06T19:00:28Z","timestamp":1770404428000},"page":"2205-2212","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Early post-approval experience of the selective cytopheretic device surveillance registry for pediatric AKI requiring kidney replacement therapy"],"prefix":"10.1007","volume":"41","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3711-8785","authenticated-orcid":false,"given":"Stuart L.","family":"Goldstein","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelli A.","family":"Krallman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meredith","family":"Harris","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajit K.","family":"Basu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David J.","family":"Askenazi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shina","family":"Menon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matt S.","family":"Zinter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen M.","family":"Gorga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harvey David","family":"Humes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily C.","family":"Scribe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David Austin","family":"Catanzaro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sai Prasad N.","family":"Iyer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin K.","family":"Chung","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,2,6]]},"reference":[{"key":"7181_CR1","doi-asserted-by":"publisher","first-page":"929","DOI":"10.1007\/s00467-023-06133-3","volume":"39","author":"DY Fuhrman","year":"2024","unstructured":"Fuhrman DY, Stanski NL, Krawczeski CD, Greenberg JH, Arikan AAA, Basu RK, Goldstein SL, Gist KM, ADQI 26 workgroup (2024) A proposed framework for advancing acute kidney injury risk stratification and diagnosis in children: a report from the 26th acute disease quality initiative (ADQI) conference. 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