Pediatric Kidney DiseaseNCT04836026
Registry for HF20 for Pediatric CRRT Under Emergency Use Authorization
An observational study of Pediatric Kidney Disease and Acute Kidney Injury, run by Children's Hospital Medical Center, Cincinnati at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatric Kidney Disease, Acute Kidney Injury
- What is being tested?
- HF20™
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Jan 2021to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
Seattle Children's
Seattle, Washington, 98105
About this study
Official title: 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.
- Conditions
- Pediatric Kidney Disease, Acute Kidney Injury
- Being tested
- HF20™
- Keywords
- HF20
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HF20™Device
HF20™ will be used for CRRT
| Study group | Role | What they receive |
|---|---|---|
| HF20™ for Pediatric CRRT | Pediatric patients in an intensive care unit requiring CRRT for acute kidney injury (AKI) Receives: Device: HF20™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Urea Nitrogen (BUN)
Measured: After 24 hours of CRRT with the HF20™ filter as compared to baseline
Secondary outcomes (2)
Change in Serum Creatinine
Measured: After 24 hours of CRRT with the HF20™ filter as compared to baseline
Change in Serum Bicarbonate/Carbon Dioxide
Measured: After 24 hours of CRRT with the HF20™ filter as compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start27 Jan 2021
- Primary completion31 Jan 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Stuart Goldstein, MD, Children's Hospital Medical Center, Cincinnati
- Investigators
- Stuart L Goldstein, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836026
- Sponsor's protocol ID
- HF20 Registry
- Status last verified
- Dec 2023
- First submitted
- 5 Apr 2021
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the HF20™ Filter for Pediatric Continuous Renal Replacement Therapy (CRRT)
- ClinicalTrials.gov ID
- NCT04836026
- Acronym / sponsor ID
- HF20 Registry
- Conditions
- Pediatric Kidney Disease, Acute Kidney Injury
- Keywords
- HF20
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HF20™ for Pediatric CRRT | – | Device: HF20™Pediatric patients in an intensive care unit requiring CRRT for acute kidney injury (AKI) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HF20™HF20™ will be used for CRRT | Device | HF20™ for Pediatric CRRT |
Primary outcome
Change in Blood Urea Nitrogen (BUN)
Time frame: After 24 hours of CRRT with the HF20™ filter as compared to baseline
2 secondary outcomes
Change in Serum Creatinine
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart L Goldstein, MD principal investigator
Children's Hospital Medical Center, Cincinnati
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Kidney Disease and Acute Kidney Injury, run by Children's Hospital Medical Center, Cincinnati at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Urea Nitrogen (BUN) (time frame: After 24 hours of CRRT with the HF20™ filter as compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.