SCD-PED Tied to Higher Survival in Septic AKI, With Stuart Goldstein, MD

Children with sepsis-associated acute kidney injury (SA-AKI) who need continuous renal replacement therapy (CRRT) had higher survival with the selective cytopheretic device for pediatrics (SCD-PED; Quelimmune) than severity-matched historical controls, investigators reported.1

Stuart Goldstein, MD, presented the data at American Society of Nephrology (ASN) Kidney Week 2026. They come from SAVE, the FDA-mandated post-approval surveillance registry for the device, and are an observational comparison against an external historical cohort. Investigators said the findings support considering SCD-PED as a safe adjunctive therapy for eligible critically ill children, while a peer-reviewed manuscript is still pending.1

Treatment options for pediatric SA-AKI remain limited and largely supportive. In a multicenter prospective pediatric CRRT registry of 116 children with multiorgan dysfunction, 39% of whom had sepsis, ICU survival was 51.7%.2

“The gap that this device and the registry attempted to address is the fact that mortality for children with AKI and sepsis requiring CRRT has been 50% for the past two and a half decades, despite many advancements in critical care,” said Goldstein, director of the Center for Acute Care Nephrology at Cincinnati Children’s Hospital Medical Center, in an interview with HCPLive.

How the Selective Cytopheretic Device Works in Pediatric Sepsis-Associated AKI

In February 2024, the FDA approved SCD-PED under a humanitarian device exemption (HDE) for patients who weigh at least 10 kg, are 22 years or younger, and have SA-AKI requiring CRRT.1,3 The device is integrated into the CRRT circuit. Activated neutrophils and monocytes bind to its membrane fibers, which lowers overall levels of inflammatory mediators.4 Goldstein explained that the cells are then released back into circulation in a less inflammatory state.

“As opposed to a single drug target, or a single cytokine target, or a single protein target, or a single component of the immune system, what the SCD does is really quiet the immune system,” Goldstein said. “These patients are still able to fight infection, but they’re immunomodulated so that the effects of sepsis that rev up the immune system to attack blood vessels and other organs is really mitigated.”

Approval rested on a pooled analysis of 22 children from 2 prospective multicenter studies, which reported 77% survival.2 As a condition of the HDE, the FDA required a post-approval registry to confirm safety and probable benefit in routine practice. An early report on the first 21 patients treated after approval found no device-related adverse events.2

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.

References

1. Kleinman 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.

2. 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/s00467-026-07181-1

3. US 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/download

4. US 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