Registry for HF20 for Pediatric CRRT Under Emergency Use Authorization

Completed

• Conditions: Acute Kidney Injury; Pediatric Kidney Disease
• Interventions: Device: HF20™

• Registration Number: NCT04836026
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-27
• Study First Submitted: 2021-04-05
• Study First Submitted QC: 2021-04-05
• Study First Posted: 2021-04-08
• Primary Completion: 2023-01-31
• Study Completion: 2023-11-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HF20™ for Pediatric CRRT	HF20™	Pediatric patients in an intensive care unit requiring CRRT for acute kidney injury (AKI)

Primary Outcome Measures

Name	Time	Method
Change in Blood Urea Nitrogen (BUN)	After 24 hours of CRRT with the HF20™ filter as compared to baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Seattle Children's; 🇺🇸 Seattle, Washington, United States

Lucile Packard Children's Hospital Stanford; 🇺🇸 Palo Alto, California, United States