Registry for HF20 for Pediatric CRRT Under Emergency Use Authorization

• Sponsor: Children's Hospital Medical Center, Cincinnati (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04836026
• Collaborator: Baxter Healthcare Corporation (Industry)
• Enrollment: 20
• Locations: 2
• Anticipated Duration (Months): 23.1
• Patients Per Site: 10
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Kidney Disease; Acute Kidney Injury	Device: HF20™

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Evaluation of the HF20™ Filter for Pediatric Continuous Renal Replacement Therapy (CRRT)
• Actual Study Start Date: Jan 27, 2021
• Anticipated Primary Completion Date: Nov 30, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Change in Blood Urea Nitrogen (BUN) [After 24 hours of CRRT with the HF20™ filter as compared to baseline]

Secondary Outcome Measures

1. Change in Serum Creatinine [After 24 hours of CRRT with the HF20™ filter as compared to baseline]

2. Change in Serum Bicarbonate/Carbon Dioxide [After 24 hours of CRRT with the HF20™ filter as compared to baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

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

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

4. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
2	Seattle Children's	Seattle	Washington	United States	98105

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Stuart L Goldstein, MD, Children's Hospital Medical Center, Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stuart Goldstein, MD, Director, Center for Acute Care Nephrology, Children's Hospital Medical Center, Cincinnati
• ClinicalTrials.gov Identifier: NCT04836026
• Other Study ID Numbers: HF20 Registry
• First Posted: Apr 8, 2021
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Stuart Goldstein, MD, Director, Center for Acute Care Nephrology, Children's Hospital Medical Center, Cincinnati: HF20
• Additional relevant MeSH terms: Kidney Diseases; Acute Kidney Injury

Study Results

No Results Posted as of Jul 20, 2022