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 <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 iCa²⁺ <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 iCa²⁺ 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 iCa²⁺ 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.

Keywords: acute kidney injury; children; continuous kidney replacement therapy; selective cytopheretic device.

Graphical abstract

Figure 1

Schematic diagram of integration of the SCD into the CKRT circuit with the direction of blood flow in the extracorporeal CKRT-SCD circuit. CKRT, continuous kidney replacement therapy; PED, pediatric; SCD, selective cytopheretic device.

Figure 2

Study subject screening and enrollment flow, with numbers of subjects who did not meet inclusion criteria and/or met exclusion criteria. A complete list of reasons for study exclusion is detailed in Supplemental Table 2. BP, blood pressure.

Figure 3

Cohort WBC counts (×10³/mcl) during the time of SCD treatment. WBC counts were obtained immediately prior to and every 12 hours after initiation of SCD treatment. The horizontal lines represent the median count, boxes the IQR, vertical line limits the upper and lower adjacent values, and dots the outlier values. IQR, interquartile range; SCD, selective cytopheretic device; WBC, white blood cell.

Figure 4

Cohort platelet counts (×10³/mcl) during the time of SCD treatment. WBC counts were obtained immediately prior to and every 12 hours after initiation of SCD treatment. The horizontal lines represent the median count, boxes the IQR, vertical line limits the upper and lower adjacent values, and dots the outlier values. IQR, interquartile range; SCD, selective cytopheretic device; WBC, white blood cell.