Registry for HF20 for Pediatric CRRT Under Emergency Use Authorization

Completed

Conditions studied: Pediatric Kidney Disease, Acute Kidney Injury

In brief

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.

Key facts

Study ID

NCT04836026

Run by

Children's Hospital Medical Center, Cincinnati

People needed

30

Starts

2021-01-27

Expected to finish

2023-11-30

Last updated by the study team

2023-12-21

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Lucile Packard Children's Hospital Stanford — Palo Alto, California, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Seattle Children's — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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