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Early post-approval experience of the selective cytopheretic device surveillance registry for pediatric AKI requiring
Stuart L Goldstein1, Kelli A Krallman2, Meredith Harris3
1University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH, 45229, USA. stuart.goldstein@cchmc.org.
Insights
The Selective Cytopheretic Device for Pediatrics (SCD-PED) shows promising safety and efficacy in critically ill children with acute kidney injury (AKI) due to sepsis. Real-world data indicate no device-related infections and favorable survival rates.
Area of Science:
- Pediatric Nephrology
- Critical Care Medicine
- Medical Device Surveillance
Background:
- The Selective Cytopheretic Device for Pediatrics (SCD-PED) received FDA Humanitarian Device Exemption (HDE) for pediatric AKI due to sepsis.
- Post-approval surveillance was mandated to gather safety data in critically ill children requiring continuous kidney replacement therapy (CKRT).
Purpose of the Study:
- To report the design and preliminary outcomes of the SCD-PED PediAtric SurVeillance REgistry (SAVE).
- To assess the safety and clinical outcomes of SCD-PED therapy in a real-world pediatric population.
Main Methods:
- The SAVE registry (NCT06517810) was established to monitor patients treated with SCD-PED under HDE.
- The primary outcome was new bloodstream infection within 28 days; secondary outcomes included mortality and KRT requirements at Days 28 and 90.
Main Results:
- Preliminary data from 21 patients showed no device-related infections, with 3 post-cessation blood cultures deemed unrelated to the device.
- Survival rates at Day 60 and Day 90 were 76% and 71%, respectively.
- No device-related adverse events were reported; 3 patients died during SCD-PED therapy.
Conclusions:
- Initial real-world experience with SCD-PED in pediatric AKI with sepsis suggests a favorable safety profile regarding infections.
- Clinical outcomes appear consistent with prior trial data, indicating potential benefits in this critically ill population.
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.
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