Registry for HF20 for Pediatric CRRT Under Emergency Use Authorization

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04836026
• Other study ID #: HF20 Registry
• Status: Completed
• Start date: January 27, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: December 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 30, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

1. AKI defined as Kidney Disease Improving Global Outcomes (KDIGO) Stage 1 or higher by either:

1. Serum creatinine criteria (0.3 mg/dL increase over baseline in 48 hours, or a 50 percent increase within the previous 7 days) or

2. Urine output criteria (less than 0.5 mL/kg/hr for 6 or more hours)

2. 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Kidney Diseases
• Pediatric Kidney Disease

Intervention

Device:
• HF20™
HF20™ will be used for CRRT

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Lucile Packard Children's Hospital Stanford	Palo Alto	California
United States	Seattle Children's	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Blood Urea Nitrogen (BUN)		After 24 hours of CRRT with the HF20™ filter as compared to baseline
Secondary	Change in Serum Creatinine		After 24 hours of CRRT with the HF20™ filter as compared to baseline
Secondary	Change in Serum Bicarbonate/Carbon Dioxide		After 24 hours of CRRT with the HF20™ filter as compared to baseline