Selective Cytopheretic Device Use in Continuous Kidney Replacement Therapy in Children: A Cohort Study With a Historical Comparator

Abstract

Rationale & ObjectiveCritically ill children with acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT) are at increased risk of death. The selective cytopheretic device (SCD) promotes an immunomodulatory effect at circuit ionized calcium <0.40 mmol/L. In an adult CRRT patient study, SCD-treated patients had improved survival/dialysis independence. We report safety data from children who received CRRT-SCD therapy and compared outcomes to a historical pediatric CRRT cohort. Study DesignWe conducted two prospective multicenter studies to evaluate safety and feasibility of SCD in critically ill children. Setting& Participants: Four pediatric institutions enrolled children >10 kg with AKI and multiorgan dysfunction receiving CRRT as standard of care with the SCD integrated post-CRRT membrane. ExposurePatients received CRRT-SCD with regional citrate anticoagulation for up to 7-10 days, or CRRT discontinuation, whichever came first. Analytical ApproachWe report serious adverse events, patient and CRRT-SCD related process and outcome variables. We compared survival to ICU discharge rates between the CRRT-SCD cohort and a matched cohort from the Prospective Pediatric CRRT (ppCRRT) registry, using odds ratios in multivariable analysis for factors associated with ppCRRT patient ICU mortality. To validate these crude analyses, Bayesian logistic regression was performed to assess for attributable benefit-risk assessment of the SCD. ResultsTwenty-two patients received CRRT-SCD treatments. Fifteen serious adverse events were recorded; none were SCD related. Seventeen patients survived to ICU discharge/Day 60. Both multivariable and Bayesian analyses revealed probable benefit of addition of SCD. Fourteen of the 16 patients surviving ICU discharge had normal eGFR and no patient was dialysis dependent at 60 days. Limitations1) Small sample size in SCD-PED cohort 2) Historical control group 3) Adverse events not recorded in control group. ConclusionsSCD therapy is feasible, safe, and demonstrates probable benefit for critically ill children who require CRRT for AKI.