Registry for HF20 for Pediatric CRRT Under Emergency Use Authorization

NCT04836026 | Completed FDA Device

• 1 other identifier: HF20 Registry
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Pediatric Kidney Disease; Acute Kidney Injury

Keywords

HF20

Outcome Measures

Primary Outcomes (1)

• Change in Blood Urea Nitrogen (BUN)

  After 24 hours of CRRT with the HF20™ filter as compared to baseline

Secondary Outcomes (2)

• 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

Study Arms (1)

HF20™ for Pediatric CRRT

Pediatric patients in an intensive care unit requiring CRRT for acute kidney injury (AKI)

Device: HF20™

Interventions

HF20™ DEVICE

HF20™ will be used for CRRT

HF20™ for Pediatric CRRT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (3)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Seattle Children's

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Stuart L Goldstein, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Acute Care Nephrology

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 8, 2021
• Study Start: January 27, 2021
• Primary Completion: January 31, 2023
• Study Completion: November 30, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)