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Registry for HF20 for Pediatric CRRT Under Emergency Use Authorization

NCT ID: NCT04836026

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-27

Study Completion Date

2023-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pediatric Kidney Disease Acute Kidney Injury

Keywords

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HF20

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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HF20™ for Pediatric CRRT

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

HF20™

Intervention Type DEVICE

HF20™ will be used for CRRT

Interventions

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HF20™

HF20™ will be used for CRRT

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Stuart Goldstein, MD

Director, Center for Acute Care Nephrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stuart L Goldstein, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Seattle Children's

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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HF20 Registry

Identifier Type: -

Identifier Source: org_study_id