Retrospective Analysis of Prismaflex HF20 Set Versus ppCRRT Registry

NCT06633029 | Completed FDA Device

• 1 other identifier: BXU602071
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 5

Brief 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. Data will be compared with a similar population (weighting 8-20 kg) from the ppCRRT registry who received CRRT with Prismaflex M60 sets.

Conditions

Acute Kidney Injury (AKI); Acute Renal Failure (ARF); Fluid Overload in Dialysis Patients

Keywords

Continuous Renal Replacement Therapy; CRRT

Outcome Measures

Primary Outcomes (2)

• Survival to CRRT discontinuation

  The proportion of patients who completed HF20/M60 based CRRT

  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

  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

  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

  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

  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)

Study Arms (1)

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

Device: Prismaflex HF20

Interventions

Prismaflex HF20 DEVICE

CRRT fluid management and reduction of uremic toxins.

Prismaflex HF20 cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Baxter Healthcare Corporation: collaborator
• Vantive Health LLC: lead

Study Sites (5)

University of Alabama at Birmingham / Children's of Alabama

Birmingham, Alabama, 35233, United States

Location

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

Ann and Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Seattle Children's Hospital Research and Foundation

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 9, 2024
• Study Start: December 11, 2024
• Primary Completion: June 25, 2025
• Study Completion: June 25, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (5)