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Use of the Selective Cytopheretic Device in Critically Ill Children
Stuart L Goldstein1, David J Askenazi2, Rajit K Basu3
1Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Insights
This study found the selective cytopheretic device (SCD) safe and feasible for critically ill children with acute kidney injury (AKI) undergoing continuous kidney replacement therapy (CKRT). The therapy showed promising survival and renal recovery rates in pediatric patients.
Area of Science:
- Pediatric Critical Care Medicine
- Nephrology
- Biomedical Engineering
Background:
- Critically ill children with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT) face high mortality risks.
- The selective cytopheretic device (SCD) offers immunomodulatory effects when used with regional citrate anticoagulation (RCA) to maintain low ionized calcium levels (<0.40 mmol/l).
- Previous adult studies indicated improved outcomes with SCD use in CRRT.
Purpose of the Study:
- To evaluate the safety and feasibility of the selective cytopheretic device (SCD) in critically ill pediatric patients with AKI requiring CKRT.
- To assess the ability to maintain target circuit ionized calcium levels (<0.40 mmol/l) using RCA during SCD therapy in children.
Main Methods:
- A US Food and Drug Administration (FDA)-sponsored study enrolled 16 critically ill children with AKI and multiorgan dysfunction across four pediatric intensive care units.
- The SCD was integrated post-CKRT membrane, utilizing RCA to maintain circuit ionized calcium (iCa2+) <0.40 mmol/l.
- SCD treatment was administered for up to 7 days or until CKRT discontinuation.
Main Results:
- The study successfully enrolled the target of 16 subjects between December 2016 and February 2020.
- Circuit ionized calcium levels were maintained below 0.40 mmol/l for 90.2% of the SCD therapy duration.
- Fifteen of sixteen subjects survived SCD therapy, with 12 surviving to ICU discharge, and all ICU survivors achieved dialysis independence at 60 days. No SCD-related adverse events were reported.
Conclusions:
- Selective cytopheretic device (SCD) therapy is demonstrated to be feasible and safe for pediatric patients requiring CKRT.
- While efficacy claims cannot be made, the observed 75% survival rate and 100% renal recovery rate suggest a potentially favorable benefit-to-risk profile.
- Further investigation into the efficacy of SCD in pediatric AKI is warranted.
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.
