Rationale & Objective: The Selective Cytopheretic Device for Pediatrics (SCD-PED) is a cell-directed extracorporeal therapy approved by US FDA for pediatric patients with acute kidney injury (AKI) due to sepsis or a septic condition, requiring antibiotics and continuous renal replacement therapy (CRRT). This study aimed to estimate hospitalization costs and outcomes of SCD-PED therapy by leveraging the Kids' Inpatient Database (KID) and SCD-PED studies. Study Design: Publicly available hospitalization cost data were combined with clinical metrics from prior SCD-PED studies to assess the impact of SCD-PED on inpatient hospital costs among pediatric patients receiving CRRT. Setting & Population: The SCD-PED was evaluated in two multicenter pediatric studies, involving 16 and 6 patients, respectively. Pediatric patients with AKI and multi-organ dysfunction receiving CRRT as part of standard care were included. The KID subset comprised hospitalizations with CRRT, a length of stay (LOS) up to 60 days, mortality and severity level 4, an AKI diagnosis, and total parenteral nutrition (TPN) procedures. Interventions: Patients received SCD-PED therapy for up to 7 or 10 days or until CRRT termination. Outcomes: Outcomes analyzed included hospital LOS, mortality, vasopressor use, mechanical ventilation, sepsis diagnosis, number of SCD-PED devices used, and hospitalization cost estimates. Model, Perspective, & Timeframe: A regression-based economic cost model compared costs between SCD-PED therapy and theoretical controls, adjusted to 2024 US dollars. Results: Modeled hospitalization costs were $457,092 in the KID cohort and $389,451 in the ppCRRT cohort. Median hospital LOS was lower in the SCD-PED group (28 days vs. 31 days), resulting in lower estimated costs ($320,304) and an estimated savings of $69,146 per hospitalization. Limitations: Small sample sizes and single-arm design with no prospective control arm. Reported costs are estimates based on models. Conclusions: The SCD-PED shows potential for survival benefit and cost-benefit in critically ill children with AKI requiring CRRT, including those with sepsis.

SPI and KKC are employees of SeaStar Medical and receive compensation in the form of salary and company stock. JK is a former employee of SeaStar Medical. NK, JK, SG, AK, and CT receive consulting fees from SeaStar Medical.

https://clinicaltrials.gov/study/NCT02820350?intr=Selective%20Cytopheretic%20Device&rank=7

Funding for this study was provided by SeaStar Medical.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

IRB of Cincinnati Childrens Hospital Medical Center gave ethical approval for this work. IRB of University of Michigan gave ethical approval for this work. IRB of Childrens Hospital of Alabama gave ethical approval for this work. IRB of Childrens Healthcare of Atlanta gave ethical approval of this work.

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All data produced in the present study are available upon reasonable request to the authors