Kidney Week

Abstract: TH-PO1291

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

Session Information

• Late-Breaking Research Posters
  October 22, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Acute Kidney Injury

• 102 AKI: Clinical, Outcomes, and Trials

Authors

• Kleinman, Nathan L., Kleinman Analytic Solutions LLC, Frisco, Texas, United States

Nathan L. Kleinman, PhD

• Goldstein, Stuart, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

Stuart Goldstein, MD, FASN

• Basu, Rajit K., Ann and Robert H Lurie Children's Hospital of Chicago Foundation, Chicago, Illinois, United States

Rajit K. Basu, MD, MS, FASN

• Mottes, Theresa Ann, Ann and Robert H Lurie Children's Hospital of Chicago Foundation, Chicago, Illinois, United States

Theresa Ann Mottes, APRN, CDN, RN

• Askenazi, David J., Children's of Alabama, Birmingham, Alabama, United States

David J. Askenazi, MD, MS, FASN

• Gorga, Stephen, University of Michigan Michigan Medicine, Ann Arbor, Michigan, United States

Stephen Gorga, MD, MSc

• Menon, Shina, Stanford Medicine, Stanford, California, United States

Shina Menon, MD, FASN

• Zinter, Matt S., UCSF Benioff Children's Hospital Oakland, Oakland, California, United States

Matt S. Zinter, MD

• Drake, Keri A., The University of Texas Southwestern Medical Center, Dallas, Texas, United States

Keri A. Drake, MD

• Zolezzi, David A., The University of Texas Southwestern Medical Center, Dallas, Texas, United States

David A. Zolezzi, PA, PA-C

• Gillespie, Robert S., Cook Children's Medical Center, Fort Worth, Texas, United States

Robert S. Gillespie, MD, MPH

• Iyer, Sai Prasad N., SeaStar Medical, Denver, Colorado, United States

Sai Prasad N. Iyer, PhD

• Scribe, Emily, SeaStar Medical, Denver, Colorado, United States

Emily Scribe, PharmD

• Chung, Kevin K., SeaStar Medical, Denver, Colorado, United States

Kevin K. Chung, MD

Background

The selective cytopheretic device for pediatrics (SCD-PED) was approved for patients ≥10 kg and ≤22 years with SA-AKI requiring CRRT under FDA humanitarian device exemption. The post-approval SAVE registry was mandated to monitor safety and clinical outcomes. We compared survival in SCD-PED treated patients (including all SAVE and one non-registry) with matched 2019 and 2022 Kids' Inpatient Database (KID) cohorts.

Methods

Children aged ≥1 year with >1 day of SCD-PED treatment in SAVE were compared with severity-matched KID patients aged 1-20 years with sepsis, CRRT, mechanical ventilation (MV), and vasopressor (VP) use/shock. Comparisons used Fisher exact tests, frequentist odds ratios, and Bayesian posterior mortality estimates with uniform Beta(1,1) priors, and survival was assessed at 28-, 60-, 90-day and in-hospital between cohorts. SAVE only outcomes included 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 SCD-PED initiation.

Results

Final cohort sizes were 43 for SAVE, and 101, 95, and 196 cases from 2019, 2022 and combined KID, respectively. Core severity markers were similar between cohorts, including sepsis, CRRT, AKI, MV, and VP use/shock, all p>0.05. Survival in SAVE was higher than KID across all comparison windows. In-hospital survival was higher in SAVE than in KID 2019 (65.1% vs 44.6%; p=0.029) and the combined 2019/2022 KID cohort (65.1% vs 46.9%; p=0.043), with Bayesian probabilities of higher SAVE survival of >95% (Figure). Additional survival comparisons favored SAVE, with >95% Bayesian probability of benefit at Days 60 and 90 vs. KID 2019, in-hospital vs. KID 2022, and Day 60 vs. combined KID. In SAVE, 83% of survivors not RRT-dependent at baseline (N=24) were RRT-free at Day 90. No device-related SAEs occurred. Secondary BSIs occurred in 12% within 28 days of SCD-PED initiation; none were device-related.

Conclusion

These real-world comparative data support consideration of SCD-PED in pediatric SA-AKI requiring CRRT as a safe adjunctive therapy that may improve outcomes and inform practice for eligible critically ill children.

Acknowledgment

This analysis used the 2019 and 2022 Kids' Inpatient Database (KID), Healthcare Cost and Utilization Project (HCUP), Agency for Healthcare Research and Quality. The authors acknowledge the HCUP Data Partners whose data contributed to the KID (https://hcup-us.ahrq.gov/db/hcupdatapartners.jsp).

Funding

• Commercial Support – SeaStar Medical