Registry for HF20 for Pediatric CRRT Under Emergency Use Authorization

Study Overview
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Brief Summary
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Historically, innovations for acute kidney injury (AKI) and continuous renal replacement therapy (CRRT) have centered around an adult population. However, research has shown that over 10% of pediatric patients develop severe AKI within the first week in an intensive care unit (ICU). When a pediatric patient requires renal replacement therapy for AKI in the ICU, CRRT is usually the modality of choice. The HF20™ is indicated for supporting patients weighing 8 to 20 kilograms, addressing a critical clinical need for critically ill children who require CRRT. Current US Food and Drug Administration (FDA) approved CRRT filters are designed for patients weighing more than 20 kg or less than 10 kg, leaving a gap in appropriately designed filters for pediatric patients. A previous trial in the US showed that the HF20™ is safe and effective, however the membrane composition of the HF20™ used in that trial is different than what is currently manufacturer and available. Baxter Healthcare Corporation has received an Emergency Use Authorization (EUA) for the currently available HF20™ to be used in the era of the COVID-19 pandemic, however participants do not need to be infected with the SAR-CoV-2 virus in order to be treated. The EUA for the HF20™ allows for treatment for any children weighing between 8 and 20 kilograms in need of CRRT. This registry will collect clinical data related to the safety and efficacy of the HF20™ filter for CRRT in pediatric patients weighing 8 to 20 kilograms at participating institutions, however participation in this registry is not a requirement in order to be treated with the HF20™ filter.

Official Title
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Evaluation of the HF20™ Filter for Pediatric Continuous Renal Replacement Therapy (CRRT)

Conditions
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Pediatric Kidney Disease, Acute Kidney Injury

Intervention / Treatment
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* Device: HF20™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receiving or plan to receive CRRT with the HF20™ filter as standard of care Acute kidney injury (AKI) or fluid overload as defined as one of the two below: AKI defined as Kidney Disease Improving Global Outcomes (KDIGO) Stage 1 or higher by either: Serum creatinine criteria (0.3 mg/dL increase over baseline in 48 hours, or a 50 percent increase within the previous 7 days) or Urine output criteria (less than 0.5 mL/kg/hr for 6 or more hours) Severe fluid overload defined as greater than 10 percent fluid accumulation based on ICU admission weight Exclusion Criteria: Weight less than 8 kilograms Weight more than 20 kilograms Patient not expected to survive more than 48 hours Received renal replacement therapy in the previous 5 days
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HF20™ for Pediatric CRRT<br>Pediatric patients in an intensive care unit requiring CRRT for acute kidney injury (AKI) | Device: HF20™<br>* HF20™ will be used for CRRT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood Urea Nitrogen (BUN) |  | After 24 hours of CRRT with the HF20™ filter as compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum Creatinine |  | After 24 hours of CRRT with the HF20™ filter as compared to baseline | 
| Change in Serum Bicarbonate/Carbon Dioxide |  | After 24 hours of CRRT with the HF20™ filter as compared to baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HF20