SCD-PED linked to higher survival in pediatric sepsis-associated AKI

Children with sepsis-associated acute kidney injury (AKI) who received the selective cytopheretic device for pediatrics (SCD-PED; QUELIMMUNE) alongside continuous renal replacement therapy (CRRT) had higher survival at 90 days and at hospital discharge than a matched historical cohort, according to an observational analysis presented as a late-breaking poster at ASN Kidney Week 2026 in Denver, Colorado.¹ Data came from SAVE, the device's FDA-mandated post-approval surveillance registry.¹

According to Stuart Goldstein, MD, director of the Center for Acute Care Nephrology at Cincinnati Children's, the data "show a significant association with higher survival and a consistent safety profile" in a clinically complex population.¹ Goldstein is a compensated member of manufacturer SeaStar Medical's scientific advisory board.¹

SAVE registry design and survival outcomes with SCD-PED

The exploratory, external-control study compared all known eligible SCD-PED–treated patients through the registry's prespecified 50-patient enrollment target, plus 1 non-registry patient, with clinically aligned children from the 2019 and 2022 Kids' Inpatient Database (KID).¹ More than 95% of patients in both cohorts required invasive mechanical ventilation, vasopressors, and/or shock management.¹

In the primary analysis, which compared patients who received more than 1 day of therapy (n = 43) with KID patients (n = 196), 90-day survival was 65.1% vs 47.4% (OR, 2.07; 95% CI, 1.04-4.11; P = .043).¹ Survival to hospital discharge was also significantly higher with SCD-PED (P = .04).¹ A landmark sensitivity analysis of patients alive 1 day after initiation showed 90-day survival of 63.8% vs 48.7%, a difference that did not reach statistical significance (OR, 1.86; 95% CI, 0.96-3.60; P = .074), although the Bayesian probability of higher survival was 96.8%.¹

All 4 time-to-event models favored SCD-PED, with hazard ratios for 90-day mortality ranging from 0.60 to 0.66; none of the frequentist models was significant, while both Bayesian models exceeded a 95% probability threshold.¹ Of 24 survivors not dependent on renal replacement therapy (RRT) at baseline, 20 (83%) were RRT-independent at day 90.¹ No device-related adverse events occurred, and all new bloodstream infections within 28 days (12% overall; 6% during treatment) were adjudicated by an independent data and safety monitoring board as unrelated to the device.¹

Mortality burden of sepsis-associated AKI requiring CRRT in children

In the international WE-ROCK cohort of 1016 patients aged 0 to 25 years receiving CRRT, the 44% with sepsis at CRRT initiation had higher mortality than those without sepsis (47% vs 31%) and more frequent major adverse kidney events at 90 days.³ With no disease-modifying therapy available, management of sepsis-associated AKI relies on supportive care, including CRRT.³

How the selective cytopheretic device works and its HDE status

The device is integrated into an existing CRRT circuit and is designed to shift activated neutrophils and monocytes toward a less inflammatory state.¹ The FDA approved it in February 2024 under a Humanitarian Device Exemption (HDE), which rests on safety and probable benefit; labeling notes that effectiveness for this use has not been demonstrated.¹,⁴ It is indicated for patients weighing at least 10 kg and aged 22 years or younger with AKI due to sepsis or a septic condition who are receiving antibiotics and require RRT in the ICU.¹ Reported adverse reactions include hypotension, hypothermia, tachycardia, hyperglycemia, and thrombocytopenia, and citrate anticoagulation is required.¹

The FDA required the SAVE registry as a condition of approval, with new bloodstream infection within 28 days as its primary outcome; the enrollment target was later reduced from 300 to 50 patients.² An earlier report of the first 21 registry patients described 76% survival at day 60 and 71% at day 90, with no device-related adverse events.²

References

1. SeaStar Medical reports statistically significant survival findings from post-approval QUELIMMUNE SAVE registry analysis in pediatric sepsis-associated AKI. News release. SeaStar Medical; October 22, 2026. Accessed October 26, 2026. https://www.globenewswire.com/news-release/2026/10/22/3386723/0/en/seastar-medical-reports-statistically-significant-survival-findings-from-post-approval-quelimmune-save-registry-analysis-in-pediatric-sepsis-associated-aki.html

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. Stanski NL, Gist KM, Hasson D, et al. Characteristics and outcomes of children and young adults with sepsis requiring continuous renal replacement therapy: a comparative analysis from the Worldwide Exploration of Renal Replacement Outcomes Collaborative in Kidney Disease (WE-ROCK). Crit Care Med. 2024;52(11):1686-1699. doi:10.1097/CCM.0000000000006405

4. US Food and Drug Administration. Summary of safety and probable benefit: QUELIMMUNE (selective cytopheretic device), HDE BH220740. February 21, 2024. Accessed October 26, 2026. https://www.fda.gov/media/176749/download