Retrospective Analysis of Prismaflex HF20 Set Versus ppCRRT Registry

Last updated: February 3, 2025
Sponsor: Baxter Healthcare Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Kidney Failure (Pediatric)

Renal Failure

Kidney Failure

Treatment

Prismaflex HF20

Prismaflex M60

Clinical Study ID

NCT06633029
BXU602071
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient weighed between 8 and 20 kg (17.6 - 44.1 lb).

  2. Patient received medical care in an intensive care unit (ICU) and was treated withHF20 based CRRT.

  3. 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.

Exclusion

Exclusion Criteria:

There are no exclusion criteria for this study.

Study Design

Total Participants: 106
Treatment Group(s): 2
Primary Treatment: Prismaflex HF20
Phase:
Study Start date:
December 11, 2024
Estimated Completion Date:
May 31, 2025

Study 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.

Connect with a study center

  • Lucile Packard Children's Hospital Stanford

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Children's Hospital Colorado

    Aurora, Colorado 80920
    United States

    Site Not Available

  • Ann and Robert H Lurie Children's Hospital of Chicago

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Children's Medical Center of Dallas

    Dallas, Texas 75235
    United States

    Site Not Available

  • Seattle Children's Hospital Research and Foundation

    Seattle, Washington 98105
    United States

    Site Not Available

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