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Background <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&#xa0;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.</p> Methods <p>The <i>S</i>CD-PED Pedi<i>A</i>tric Sur<i>V</i>eillance R<i>E</i>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&#xa0;days after SCD-PED initiation. Additional Day 28 and Day 90 clinical outcomes including mortality and KRT requirement will be collected.</p> Results <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.</p> Conclusion <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.</p> Graphical abstract <p></p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月6日

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  • Stuart L. Goldstein,
  • Kelli A. Krallman,
  • Meredith Harris,
  • Rajit K. Basu,
  • David J. Askenazi,
  • Shina Menon,
  • Matt S. Zinter,
  • Stephen M. Gorga,
  • Harvey David Humes,
  • Emily C. Scribe,
  • David Austin Catanzaro,
  • Sai Prasad N. Iyer,
  • Kevin K. Chung

摘要

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.

Graphical abstract