Registry for HF20 for Pediatric CRRT Under Emergency Use Authorization

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Pediatric Kidney Disease
• Intervention / Treatment: Device: HF20™

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Lucile Packard Children's Hospital Stanford
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving CRRT with the HF20™ filter as their standard care for AKI or fluid overload in an intensive care unit at a participating institution.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HF20™ for Pediatric CRRT; Pediatric patients in an intensive care unit requiring CRRT for acute kidney injury (AKI)	Device: HF20™; HF20™ will be used for CRRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Stuart L Goldstein, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2021
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: HF20
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Acute Kidney Injury
• Other Study ID Numbers: HF20 Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No