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Selective Cytopheretic Device Use in Continuous Kidney Replacement Therapy in Children: A Cohort Study With a
Stuart L Goldstein1, Nicholas J Ollberding2, David J Askenazi3
1Division of Nephrology & Hypertension, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Insights
Selective cytopheretic device (SCD) therapy is safe and feasible for critically ill children with acute kidney injury (AKI) undergoing continuous renal replacement therapy (CRRT), showing probable survival benefits.
Area of Science:
- Pediatric Nephrology
- Critical Care Medicine
- Biomedical Engineering
Background:
- Critically ill children with acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT) face high mortality risks.
- The selective cytopheretic device (SCD) offers immunomodulatory effects, with prior adult studies suggesting improved survival and dialysis independence.
Purpose of the Study:
- To evaluate the safety and feasibility of CRRT integrated with the SCD (CRRT-SCD) in critically ill children.
- To compare survival outcomes of pediatric patients treated with CRRT-SCD against a historical CRRT cohort.
Main Methods:
- Prospective, multicenter studies involving 22 critically ill children (≥10 kg) with AKI and multi-organ dysfunction receiving CRRT-SCD.
- Comparison of survival rates and renal function (estimated glomerular filtration rate, dialysis dependence) with a matched historical pediatric CRRT cohort using multivariable and Bayesian analyses.
Main Results:
- Fifteen serious adverse events were reported, none related to the SCD.
- Seventeen out of 22 patients survived to ICU discharge or day 60.
- Both analytical approaches indicated a probable benefit from adding SCD, with most survivors showing normal kidney function and no dialysis dependence at 60 days.
Conclusions:
- CRRT-SCD therapy is safe and feasible in critically ill pediatric patients with AKI.
- The addition of SCD to CRRT in children demonstrates a probable survival benefit.
- Further research with larger sample sizes is warranted to confirm these findings.
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.
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