Retrospective Analysis of Prismaflex HF20 Set Versus ppCRRT Registry

Baxter Healthcare Corporation106 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

106

Conditions

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

Interventions

Prismaflex HF20DEVICE

CRRT fluid management and reduction of uremic toxins.

Prismaflex M60DEVICE

CRRT fluid management and reduction of uremic toxins.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (6)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States

RECRUITING

Children's Hospital Colorado

Aurora, Colorado, United States

NOT_YET_RECRUITING

Ann and Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Survival to CRRT discontinuation

The proportion of patients who completed HF20/M60 based CRRT

Time frame: 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

Time frame: 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

ICU length of stay

The duration of time (in days) patients were in the ICU

CRRT duration

The duration of time (in days) HF20/M60 based CRRT was performed

Time frame: 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

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).

Time frame: 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)

Central Contacts

Baxter CORP Clinical Trials Disclosure

CONTACT

(224) 948-7359 Global_CORP_ClinicalTrialsDisclosure@baxter.com

Data from ClinicalTrials.gov

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