{"doi":"10.1007/s00467-026-07181-1","title":"Early post-approval experience of the selective cytopheretic device surveillance registry for pediatric AKI requiring kidney replacement therapy","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 ≥ 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.</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 days 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>","journal":"Pediatric Nephrology","year":2026,"id":652629,"datarank":0.10397207708399181,"base_score":0.6931471805599453,"endowment":0.6931471805599453,"self_citation_contribution":0.10397207708399181,"citation_network_contribution":0.0,"self_endowment_contribution":0.10397207708399181,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":1,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":336744,"name":"Kelli A. Krallman","orcid":"0000-0002-3275-2982","position":1,"is_corresponding":false},{"id":746364,"name":"Meredith Harris","orcid":"0000-0003-0096-729X","position":2,"is_corresponding":false},{"id":336746,"name":"Rajit K. Basu","orcid":"0000-0002-3184-341X","position":3,"is_corresponding":false},{"id":336745,"name":"David J. Askenazi","orcid":"0000-0002-6840-9887","position":4,"is_corresponding":false},{"id":486344,"name":"Shina Menon","orcid":"0000-0001-8473-0307","position":5,"is_corresponding":false},{"id":746065,"name":"Matt S. Zinter","orcid":"0000-0003-3351-3278","position":6,"is_corresponding":false},{"id":645265,"name":"Stephen M. Gorga","orcid":null,"position":7,"is_corresponding":false},{"id":1702513,"name":"Harvey David Humes","orcid":null,"position":8,"is_corresponding":false},{"id":1702514,"name":"Emily C. Scribe","orcid":null,"position":9,"is_corresponding":false},{"id":1702515,"name":"David Austin Catanzaro","orcid":null,"position":10,"is_corresponding":false},{"id":1702516,"name":"Sai Prasad N. Iyer","orcid":null,"position":11,"is_corresponding":false},{"id":252184,"name":"Kevin K. Chung","orcid":"0000-0002-2781-3787","position":12,"is_corresponding":false},{"id":108942,"name":"Stuart L. Goldstein","orcid":"0000-0003-3711-8785","position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Early post-approval experience of the selective cytopheretic device surveillance registry for pediatric AKI requiring kidney replacement therapy","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 ≥ 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.</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 days 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>","is_dataset_classified":null,"base_score":0.6931471805599453,"endowment":0.6931471805599453,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"41652244","pmcid":"PMC13197363","openalex_id":"https://openalex.org/W7128164673","authors":[],"funders":[],"total_grants":0,"fwci":7.6156,"citation_percentile":0.93488338,"influential_citations":0,"citation_trend":[{"year":2026,"count":1}],"oa_status":"hybrid","license":"cc-by","oa_locations":[{"url":"https://link.springer.com/content/pdf/10.1007/s00467-026-07181-1.pdf","host_type":"journal"},{"url":"https://link.springer.com/content/pdf/10.1007/s00467-026-07181-1.pdf","host_type":"publisher"},{"url":"https://link.springer.com/article/10.1007/s00467-026-07181-1","host_type":"publisher"},{"url":"https://doi.org/10.1007/s00467-026-07181-1","host_type":"journal"},{"url":"https://pubmed.ncbi.nlm.nih.gov/41652244","host_type":"repository"},{"url":"https://europepmc.org/articles/PMC13197363","host_type":"Europe_PMC"},{"url":"https://europepmc.org/articles/PMC13197363?pdf=render","host_type":"Europe_PMC"}],"fields_of_study":["Acute Kidney Injury Research","Sepsis Diagnosis and Treatment","Trauma, Hemostasis, Coagulopathy, Resuscitation","Adolescent","Child","Child, Preschool","Female","Humans","Infant","Male","Acute Kidney Injury","Continuous Renal Replacement Therapy","Device Approval","Product Surveillance, Postmarketing","Registries","Renal Replacement Therapy","Sepsis","Treatment Outcome","United States","United States Food and Drug Administration"],"mesh_terms":["Continuous Renal Replacement Therapy","Adolescent","Child","Child, Preschool","Female","Humans","Infant","Male","Product Surveillance, Postmarketing","Registries","United States","United States Food and Drug Administration","Critical Illness","Treatment Outcome","Renal Replacement Therapy","Device Approval","Sepsis","Acute Kidney Injury"],"keywords":["Renal replacement therapy","Nephrology","Acute kidney injury","Sepsis","Critically ill","MEDLINE","Immunomodulation","SCD","Kidney Replacement Therapy","Selective Cytopheretic Device"],"sdg_mappings":[],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[{"name":"nct"}],"source":"live","citation_network_status":"fetched"},"created_at":"2026-08-10T16:18:30.741127Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}