Retrospective Analysis of Prismaflex HF20 Set Versus ppCRRT Registry

Baxter

Status: Enrolling

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

Treatments: Device: Prismaflex M60; Device: Prismaflex HF20

Study type: Observational

Funder types: Industry

Identifiers

NCT06633029

BXU602071

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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 with HF20 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 criteria

There are no exclusion criteria for this study.

Trial design

106 participants in 2 patient groups

Prismaflex HF20 cohort

Description:

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

Treatment:

Device: Prismaflex HF20

Prismaflex M60 cohort

Description:

Data from ppCRRT registry used for comparison Pediatrics (weighing between 8 and 20 kg) who received CRRT with Prismaflex M60 sets

Treatment:

Device: Prismaflex M60