Abstract
RATIONALE AND OBJECTIVE: Critically 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 of <0.40 mmol/L. In an adult CRRT patient study, SCD-treated patients reported improved survival or dialysis independence. We reported safety data from children who received CRRT-SCD therapy and compared outcomes with a historic pediatric CRRT cohort. STUDY DESIGN: We performed 2 prospective multicenter studies to evaluate the safety and feasibility of SCD in critically ill children. SETTING AND PARTICIPANTS: Four pediatric institutions enrolled children weighing 10 kg or more with AKI and multi-organ dysfunction receiving CRRT as the standard of care with the SCD-integrated post-CRRT membrane. EXPOSURE: Patients received CRRT-SCD with regional citrate anticoagulation for up to 7-10 days, or CRRT discontinuation, whichever came first. ANALYTICAL APPROACH: We reported serious adverse events among patients and CRRT-SCD-related process and outcome variables. We compared survival to intensive care unit (ICU) discharge rates between the CRRT-SCD cohort and a matched cohort from the prospective pediatric CRRT registry, using odds ratios in multivariable analysis for factors associated with prospective pediatric CRRT patient ICU mortality. To validate these crude analyses, Bayesian logistic regression was performed to assess for attributable benefit-risk assessment of the SCD. RESULTS: Twenty-two patients received CRRT-SCD treatments. Fifteen serious adverse events were recorded; none were SCD-related. Seventeen patients survived till ICU discharge or day 60. Both multivariable and Bayesian analyses revealed a probable benefit of the addition of SCD. Fourteen of the 16 patients surviving ICU discharge reported a normal estimated glomerular filtration rate and no patient was dialysis dependent at 60 days. LIMITATIONS: The study had a few limitations, such as (1) a small sample size in the SCD-PED cohort group; (2) unchanging historic control group; and (3) adverse events were not recorded in the control group. CONCLUSIONS: The SCD therapy is feasible, safe, and demonstrates probable benefit for critically ill children who require CRRT for AKI.