Retrospective Analysis of Prismaflex HF20 Set Versus ppCRRT Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-11

Study Completion Date

2025-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Prismaflex HF20

Intervention Type DEVICE

CRRT fluid management and reduction of uremic toxins.

Prismaflex M60 cohort

Data from ppCRRT registry used for comparison

Pediatrics (weighing between 8 and 20 kg) who received CRRT with Prismaflex M60 sets

Prismaflex M60

Intervention Type DEVICE

CRRT fluid management and reduction of uremic toxins.

Interventions

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Prismaflex HF20

CRRT fluid management and reduction of uremic toxins.

Intervention Type DEVICE

Prismaflex M60

CRRT fluid management and reduction of uremic toxins.

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No