Acute Renal Failure (ARF)NCT06633029
Retrospective Analysis of Prismaflex HF20 Set Versus ppCRRT Registry
An observational study of Acute Renal Failure (ARF) and Acute Kidney Injury (AKI), run by Vantive Health LLC at 5 sites in United States.
Trial summary
A retrospective multicenter, observational design intended to capture data on pediatrics (weighing between 8 - 20 kg) who underwent continuous renal replacement therapy (CRRT) using the HF20 set. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Renal Failure (ARF), Acute Kidney Injury (AKI), Fluid Overload in Dialysis Patients
- What is being tested?
- Prismaflex HF20
- Type of treatment
- Medical device
- How many people
- 59 participants
- Where
- 5 sitesUnited States
- Study dates
- 11 Dec 2024to 25 Jun 2025
- 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: Data from approximately 40 pediatric patients who had acute kidney injury (AKI), acute renal failure (ARF) or fluid overload requiring CRRT, weighed between 8 and 20 kg (17.6-44.1 lb), and were treated in the ICU with marketed HF20 based CRRT between 2008 to current in Canada or with HF20 product available under EUA between 2020 to current in the US, will be collected. Data will be compared with a similar population (weighing 8-20 kg) from the ppCRRT registry who received CRRT with Prismaflex M60 sets.
Who may be able to join
- Patient weighed between 8 and 20 kg (17.6 - 44.1 lb).
- Patient received medical care in an intensive care unit (ICU) and was treated with HF20 based CRRT.
- Patient had a clinical diagnosis of AKI or ARF or fluid overload requiring CRRT.
- Note: The cohort of patients treated with M60 sets from the ppCRRT registry (weighing 8 - 20 kg) are to meet inclusion criteria 1 and 3.
Who cannot join
- There are no exclusion criteria for this study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Alabama at Birmingham / Children's of Alabama
Birmingham, Alabama, 35233
Ann and Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
Seattle Children's Hospital Research and Foundation
Seattle, Washington, 98105
About this study
Official title: Comparison of Patient Outcomes Between Retrospective Prismaflex HF20 Set and Historical Prospective Pediatric Continuous Renal Replacement Therapy (ppCRRT) Registry
A retrospective multicenter, observational design intended to capture data on pediatrics (weighing between 8 - 20 kg) who underwent continuous renal replacement therapy (CRRT) using the HF20 set. Data will be compared with a similar population (weighting 8-20 kg) from the ppCRRT registry who received CRRT with Prismaflex M60 sets.
Read the detailed description
This study aims to compare patient outcomes after treatment with HF20 based CRRT to the historical ppCRRT registry. Data from eligible patient records will be collected, starting from January 2008 to most recent in Canada and from January 2020 to most recent in the US.
The ppCRRT registry used a prospective observational format whereby de-identified data on patients and CRRT circuits were collected from 13 participating centers across the US between 2001 JAN 01 and 2005 AUG 31. The registry's primary outcome measure was patient survival to ICU discharge.
- Being tested
- Prismaflex HF20
- Keywords
- Continuous Renal Replacement Therapy, CRRT
- 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.
Prismaflex HF20Device
CRRT fluid management and reduction of uremic toxins.
| Study group | Role | What they receive |
|---|---|---|
| Prismaflex HF20 cohort | Data collected from this study
Pediatrics (weighing between 8 and 20 kg) who received CRRT with Prismaflex HF20 between 2008 to current in Canada or between 2020 to current in the US Receives: Device: Prismaflex HF20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to CRRT discontinuation
The proportion of patients who completed HF20/M60 based CRRT
Measured: From CRRT initiation up to CRRT discontinuation of the first record of CRRT treatment with HF20/M60 (from January 2008 to present in Canada, and from January 2020 to present in the US)
Survival to ICU discharge
The proportion of patients who were released from the ICU
Measured: From ICU admission up to ICU discharge as related to of the first record of CRRT treatment with HF20/M60 (from January 2008 to present in Canada, and from January 2020 to present in the US)
Secondary outcomes (3)
ICU length of stay
The duration of time (in days) patients were in the ICU
Measured: From ICU admission up to ICU discharge as related to of the first record of CRRT treatment with HF20/M60 (from January 2008 to present in Canada, and from January 2020 to present in the US)
CRRT duration
The duration of time (in days) HF20/M60 based CRRT was performed
Measured: From CRRT initiation up to CRRT discontinuation of the first record of CRRT treatment with HF20/M60 (from January 2008 to present in Canada, and from January 2020 to present in the US)
AEs of relevance for HF20
AEs of relevance (non-serious and serious) documented in the patient's medical records that occurred during HF20 based CRRT treatment within the collection period (i.e., from 2008 to present for patients in Canada or 2020 to present for US patients).
Measured: From CRRT initiation up to CRRT discontinuation of the first record of CRRT treatment with HF20 (from January 2008 to present in Canada, and from January 2020 to present in the US)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start11 Dec 2024
- Primary completion25 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal Failure (ARF)Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633029
- Sponsor's protocol ID
- BXU602071
- Status last verified
- Feb 2026
- First submitted
- 2 Oct 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patient Outcomes Between Retrospective Prismaflex HF20 Set and Historical Prospective Pediatric Continuous Renal Replacement Therapy (ppCRRT) Registry
- ClinicalTrials.gov ID
- NCT06633029
- Acronym / sponsor ID
- BXU602071
- Keywords
- Continuous Renal Replacement Therapy, CRRT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 9 Oct 2024 (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.
A retrospective multicenter, observational design intended to capture data on pediatrics (weighing between 8 - 20 kg) who underwent continuous renal replacement therapy (CRRT) using the HF20 set. Data will be compared with a similar population (weighting 8-20 kg) from the ppCRRT registry who received CRRT with Prismaflex M60 sets.
Detailed description
This study aims to compare patient outcomes after treatment with HF20 based CRRT to the historical ppCRRT registry. Data from eligible patient records will be collected, starting from January 2008 to most recent in Canada and from January 2020 to most recent in the US.
The ppCRRT registry used a prospective observational format whereby de-identified data on patients and CRRT circuits were collected from 13 participating centers across the US between 2001 JAN 01 and 2005 AUG 31. The registry's primary outcome measure was patient survival to ICU discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prismaflex HF20 cohort | – | Device: Prismaflex HF20Data collected from this study Pediatrics (weighing between 8 and 20 kg) who received CRRT with Prismaflex HF20 between 2008 to current in Canada or between 2020 to current in the US |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Data from approximately 40 pediatric patients who had acute kidney injury (AKI), acute renal failure (ARF) or fluid overload requiring CRRT, weighed between 8 and 20 kg (17.6-44.1 lb), and were treated in the ICU with marketed HF20 based CRRT between 2008 to current in Canada or with HF20 product available under EUA between 2020 to current in the US, will be collected. Data will be compared with a similar population (weighing 8-20 kg) from the ppCRRT registry who received CRRT with Prismaflex M60 sets.
Key inclusion criteria (4 listed)
- Patient weighed between 8 and 20 kg (17.6 - 44.1 lb).
- Patient received medical care in an intensive care unit (ICU) and was treated with HF20 based CRRT.
- Patient had a clinical diagnosis of AKI or ARF or fluid overload requiring CRRT.
- Note: The cohort of patients treated with M60 sets from the ppCRRT registry (weighing 8 - 20 kg) are to meet inclusion criteria 1 and 3.
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study.
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 |
|---|---|---|
| Prismaflex HF20CRRT fluid management and reduction of uremic toxins. | Device | Prismaflex HF20 cohort |
Primary outcome
Survival to CRRT discontinuation
Time frame: From CRRT initiation up to CRRT discontinuation of the first record of CRRT treatment with HF20/M60 (from January 2008 to present in Canada, and from January 2020 to present in the US)
The proportion of patients who completed HF20/M60 based CRRT
Survival to ICU discharge
Time frame: From ICU admission up to ICU discharge as related to of the first record of CRRT treatment with HF20/M60 (from January 2008 to present in Canada, and from January 2020 to present in the US)
The proportion of patients who were released from the ICU
3 secondary outcomes
ICU length of stay
Time frame: From ICU admission up to ICU discharge as related to of the first record of CRRT treatment with HF20/M60 (from January 2008 to present in Canada, and from January 2020 to present in the US)
CRRT duration
Time frame: From CRRT initiation up to CRRT discontinuation of the first record of CRRT treatment with HF20/M60 (from January 2008 to present in Canada, and from January 2020 to present in the US)
AEs of relevance for HF20
Time frame: From CRRT initiation up to CRRT discontinuation of the first record of CRRT treatment with HF20 (from January 2008 to present in Canada, and from January 2020 to present in the US)
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 17 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Renal Failure (ARF) and Acute Kidney Injury (AKI), run by Vantive Health LLC at 5 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 4 inclusion and 1 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 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Survival to CRRT discontinuation (time frame: From CRRT initiation up to CRRT discontinuation of the first record of CRRT treatment with HF20/M60 (from January 2008 to present in Canada, and from January 2020 to present in the US)). The study lists 2 primary outcomes in all. 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 17 Feb 2026.