Use of the Selective Cytopheretic Device in Critically Ill Children

Abstract 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 (iCa2+) is maintained at Methods Four pediatric 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 iCa2+ Results The FDA target enrollment of 16 subjects completed the study from 12/2016-2/2020. 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 iCa2+ were maintained at Conclusion Our data demonstrate SCD therapy is feasible and safe in children who require CKRT. While we cannot make efficacy claims, the 75% survival rate and 100% renal recovery rate observed suggest a possible favorable benefit-to-risk ratio.