Retrospective Analysis of Prismaflex HF20 Set Versus ppCRRT Registry

Recruiting

• Conditions: Acute Renal Failure (ARF); Acute Kidney Injury (AKI); Fluid Overload in Dialysis Patients
• Interventions: Device: Prismaflex HF20; Device: Prismaflex M60

• Registration Number: NCT06633029
• Lead Sponsor: Baxter Healthcare Corporation

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.

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 Timeline

• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-07
• Study First Posted: 2024-10-09
• Study Start: 2024-12-11
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prismaflex HF20 cohort	Prismaflex HF20	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 M60 cohort	Prismaflex M60	Data from ppCRRT registry used for comparison Pediatrics (weighing between 8 and 20 kg) who received CRRT with Prismaflex M60 sets

Primary Outcome Measures

Name	Time	Method
Survival to CRRT discontinuation	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	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

Secondary Outcome Measures

Name	Time	Method
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)	The duration of time (in days) patients were in the ICU
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)	The duration of time (in days) HF20/M60 based CRRT was performed
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)	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).

Trial Locations

Locations (6)

Lucile Packard Children's Hospital Stanford; 🇺🇸 Palo Alto, California, United States

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Ann and Robert H Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Children's Medical Center of Dallas; 🇺🇸 Dallas, Texas, United States

Seattle Children's Hospital Research and Foundation; 🇺🇸 Seattle, Washington, United States