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NCT04836026 · ClinicalTrials.gov registry record
Registry for HF20 for Pediatric CRRT Under Emergency Use Authorization
A clinical trial, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- 30
- Enrollment target
NCT04836026 is a clinical trial that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 30 participants.
The verdict
NCT04836026 has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
Study 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.
Interventions
- DEVICE HF20™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-01-27 |
| Est. Completion | 2023-11-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04836026
The ClinicalTrials.gov registry entry for NCT04836026 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which HF20™ is the first listed.
NCT04836026 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04836026 about?
NCT04836026 is a clinical study titled "Registry for HF20 for Pediatric CRRT Under Emergency Use Authorization". 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...
What is the current status of trial NCT04836026?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2021-01-27. Estimated completion is 2023-11-30.
What interventions are being tested in trial NCT04836026?
The interventions under investigation include: HF20™ (DEVICE).
Who is sponsoring clinical trial NCT04836026?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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