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Abstract: TH-PO039

Multi-Center Study to Assess the Safety of a Selective Cytopheretic Device (SCD) for Treatment of Immunomodulatory Dysregulation due to AKI in Children ≥10 and ≤20 kg: Report From the First 4 Patients

Session Information

Category: Acute Kidney Injury

  • 102 AKI: Clinical‚ Outcomes‚ and Trials

Authors

  • Krallman, Kelli A., Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
  • French, Xavier, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
  • Humes, H. David, University of Michigan Medical School, Ann Arbor, Michigan, United States
  • Askenazi, David J., Benjamin Russell Hospital for Children, Birmingham, Alabama, United States
  • Yessayan, Lenar Tatios, University of Michigan Medical School, Ann Arbor, Michigan, United States
  • Collins, Michaela, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
  • Potts, Jessica, Benjamin Russell Hospital for Children, Birmingham, Alabama, United States
  • Goldstein, Stuart, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Background

Acute kidney injury (AKI) that requires continuous kidney replacement therapy (CKRT) is a highly lethal condition in critically ill patients. Despite improvements in acute care and dialysis therapies, the mortality rate from the past four decades has not improved. In a previous single treatment arm study of children on CKRT treated with SCD > 20 kg, 12/16 subjects survived to ICU discharge, all of whom were dialysis independent by day 60. We now report outcomes in findings the first 4 treated patients < 20 kg.

Methods

4 center US study of SCD in children that weigh between ≥10 and ≤ 20kg, have a clinical diagnosis of AKI requiring CKRT and at least one non-renal organ failure. With these subjects the SCD was integrated post CKRT membrane, changed daily, and circuit ionized calcium (iCa) maintained <0.4 mmol/L. Subjects received SCD treatment for up to 10 days or CKRT discontinuation, whichever came first.

Results

5 patients (2F/3M) have been enrolled since 07/2021. Four patients (Age 1.6 - 10.4 years. PRISM-2 Score range = 14-27) received SCD therapy. Three of these patients received SCD on a PRISMAFLEX™ one on a PRISMAX™ machine. Circuit iCa has been maintained at <0.4 mmol/L during 81% of therapy. Three of the four patients demonstrated renal recovery after SCD therapy, coming off all forms of KRT within 5 days post SCD therapy. Of the patients that have reached day 60, both were dialysis independent. The fourth patient died after SCD therapy had ended but before ICU discharge. An additional patient was enrolled but did not continue with SCD because their iCa was not in range due to citrate intolerance. No SCD-related serious adverse events have been reported.

Conclusion

Our initial findings suggest that SCD is safe in critically ill pediatric patients weighing between 10-20kg.

Patient Information
Patient NumberAge (yrs)Weight (Kg)DiagnosisFinal Outcome
11.914.1Shock and pancytopeniaAlive with renal recovery
21.712Necrotizing pneumoniaDeceased
310.416.5Status epilepticusAlive with renal recovery
43.514.3Bowel perforation and septic shockOngoing but off KRT

Funding

  • Private Foundation Support