PMID- 33732992 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220421 IS - 2468-0249 (Electronic) IS - 2468-0249 (Linking) VI - 6 IP - 3 DP - 2021 Mar TI - Use of the Selective Cytopheretic Device in Critically Ill Children. PG - 775-784 LID - 10.1016/j.ekir.2020.12.010 [doi] AB - INTRODUCTION: Critically ill children with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT) are at increased risk of death. The selective cytopheretic device (SCD) promotes an immunomodulatory effect when circuit ionized calcium (iCa(2+)) is maintained at <0.40 mmol/l with regional citrate anticoagulation (RCA). In a randomized trial of adult patients on CRRT, those treated with the SCD maintaining an iCa(2+) <0.40 mmol/l had improved survival/dialysis independence. We conducted a US Food and Drug Administration (FDA)-sponsored study to evaluate safety and feasibility of the SCD in 16 critically ill children. METHODS: Four pediatric intensive care units (ICUs) enrolled children with AKI and multiorgan dysfunction receiving CKRT to receive the SCD integrated post-CKRT membrane. RCA was used to achieve a circuit iCa(2+) level <0.40 mmol/l. Subjects received SCD treatment for 7 days or CKRT discontinuation, whichever came first. RESULTS: The FDA target enrollment of 16 subjects completed the study from December 2016 to February 2020. Mean age was 12.3 +/- 5.1 years, weight was 53.8 +/- 28.9 kg, and median Pediatric Risk of Mortality II was 7 (range 2-19). Circuit iCa(2+) levels were maintained at <0.40 mmol/l for 90.2% of the SCD therapy time. Median SCD duration was 6 days. Fifteen subjects survived SCD therapy; 12 survived to ICU discharge. All ICU survivors were dialysis independent at 60 days. No SCD-related adverse events (AEs) were reported. CONCLUSION: Our data demonstrate that SCD therapy is feasible and safe in children who require CKRT. Although we cannot make efficacy claims, the 75% survival rate and 100% renal recovery rate observed suggest a possible favorable benefit-to-risk ratio. CI - (c) 2020 International Society of Nephrology. Published by Elsevier Inc. FAU - Goldstein, Stuart L AU - Goldstein SL AD - Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA. FAU - Askenazi, David J AU - Askenazi DJ AD - University of Alabama at Birmingham, Birmingham, Alabama, USA. FAU - Basu, Rajit K AU - Basu RK AD - Children's Healthcare of Atlanta, Atlanta, Georgia, USA. FAU - Selewski, David T AU - Selewski DT AD - Medical University of South Carolina, Charleston, South Carolina, USA. FAU - Paden, Matthew L AU - Paden ML AD - Children's Healthcare of Atlanta, Atlanta, Georgia, USA. FAU - Krallman, Kelli A AU - Krallman KA AD - Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA. FAU - Kirby, Cassie L AU - Kirby CL AD - Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA. FAU - Mottes, Theresa A AU - Mottes TA AD - Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA. FAU - Terrell, Tara AU - Terrell T AD - Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA. FAU - Humes, H David AU - Humes HD AD - University of Michigan, Ann Arbor, Michigan, USA. LA - eng PT - Journal Article DEP - 20201219 PL - United States TA - Kidney Int Rep JT - Kidney international reports JID - 101684752 PMC - PMC7938071 OTO - NOTNLM OT - acute kidney injury OT - children OT - continuous kidney replacement therapy OT - selective cytopheretic device EDAT- 2021/03/19 06:00 MHDA- 2021/03/19 06:01 PMCR- 2020/12/19 CRDT- 2021/03/18 06:55 PHST- 2020/11/09 00:00 [received] PHST- 2020/12/08 00:00 [revised] PHST- 2020/12/09 00:00 [accepted] PHST- 2021/03/18 06:55 [entrez] PHST- 2021/03/19 06:00 [pubmed] PHST- 2021/03/19 06:01 [medline] PHST- 2020/12/19 00:00 [pmc-release] AID - S2468-0249(20)31841-6 [pii] AID - 10.1016/j.ekir.2020.12.010 [doi] PST - epublish SO - Kidney Int Rep. 2020 Dec 19;6(3):775-784. doi: 10.1016/j.ekir.2020.12.010. eCollection 2021 Mar.