SAVE Registry Design: SCD-PED vs Kids’ Inpatient Database Controls
The analysis included children aged 1 year or older who received more than 1 day of SCD-PED treatment in SAVE, plus 1 patient treated outside the registry. Investigators compared them with severity-matched patients aged 1 to 20 years from the 2019 and 2022 Kids’ Inpatient Database (KID) who had sepsis, CRRT, mechanical ventilation, and vasopressor use or shock.1
Survival was assessed at 28, 60, and 90 days and to hospital discharge. Comparisons used Fisher exact tests, frequentist odds ratios, and Bayesian posterior estimates with uniform priors. Outcomes measured only in SAVE were Day 90 renal replacement therapy (RRT) status in patients not RRT-dependent at baseline, serious adverse events (SAEs), and new secondary bloodstream infections (BSIs) within 28 days of starting the device.1
SCD-PED Survival and Dialysis Independence Outcomes
The final cohorts were 43 patients in SAVE and 101, 95, and 196 cases from KID 2019, KID 2022, and the combined KID cohort, respectively. Core severity markers were similar between groups, including sepsis, CRRT, AKI, mechanical ventilation, and vasopressor use or shock (all P >.05).1
Survival was higher in SAVE than in KID across all comparison windows. In-hospital survival was 65.1% in SAVE compared with 44.6% in KID 2019 (P = .029) and 46.9% in the combined KID cohort (P = .043). The Bayesian probability of higher survival in SAVE exceeded 95% for both comparisons.1
Other comparisons also favored SAVE, with a Bayesian probability of benefit above 95% at Days 60 and 90 vs KID 2019, for in-hospital survival vs KID 2022, and at Day 60 vs the combined KID cohort.1
Among the 24 survivors who were not RRT-dependent at baseline, 83% were RRT-free at Day 90. There were no device-related SAEs. Secondary BSIs occurred in 12% of patients within 28 days of starting the device, and none were device-related.1
The analysis was observational, small, and compared registry patients against an administrative database rather than concurrent controls. The investigators described the results as real-world comparative data.
Expanding SCD-PED Use Beyond the Humanitarian Device Exemption
Goldstein said he hopes growing registry experience will eventually support use beyond the HDE’s strict criteria. That could include children with sepsis who do not need CRRT, or other highly proinflammatory states.
“But in a clinical setting, we have to practice under the guidelines of the humanitarian device exemption,” he said.
Editor’s Note: Goldstein reports relevant disclosures with SeaStar Medical.
ReferencesKleinman NL, Zolezzi DA, Gillespie RS, et al. Improved outcomes in pediatric sepsis-associated (SA) AKI: comparison of the selective cytopheretic device for pediatrics (SCD-PED) surveillance registry (SAVE) with a historical cohort. Abstract presented at: ASN Kidney Week 2026; October 21-25, 2026; Denver, CO.Goldstein SL, Krallman KA, Harris M, et al. Early post-approval experience of the selective cytopheretic device surveillance registry for pediatric AKI requiring kidney replacement therapy. Pediatr Nephrol. 2026;41(7):2205-2212. doi:10.1007/s00467-026-07181-1US Food and Drug Administration. Summary of safety and probable benefit: QUELIMMUNE (selective cytopheretic device), HDE BH220740. Published February 2024. Accessed November 2, 2026. https://www.fda.gov/media/176749/downloadUS Food and Drug Administration. Safety and utilization review for the Pediatric Advisory Committee: selective cytopheretic device for pediatrics (SCD-PED), HDE BH220740. Pediatric Advisory Committee Meeting; November 2025. Accessed November 2, 2026. https://www.fda.gov/media/189568/download