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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
California
-
Palo Alto, California, United States, 94304
- Lucile Packard Children's Hospital Stanford
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-
Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Washington
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Seattle, Washington, United States, 98105
- Seattle Children's
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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:
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
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)
|
HF20™ will be used for CRRT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Blood Urea Nitrogen (BUN)
Time Frame: After 24 hours of CRRT with the HF20™ filter as compared to baseline
|
After 24 hours of CRRT with the HF20™ filter as compared to baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Serum Creatinine
Time Frame: After 24 hours of CRRT with the HF20™ filter as compared to baseline
|
After 24 hours of CRRT with the HF20™ filter as compared to baseline
|
|
Change in Serum Bicarbonate/Carbon Dioxide
Time Frame: After 24 hours of CRRT with the HF20™ filter as compared to baseline
|
After 24 hours of CRRT with the HF20™ filter as compared to baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Stuart L Goldstein, MD, Children's Hospital Medical Center, Cincinnati
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HF20 Registry
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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