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Completed

NCT Number: NCT06633029

Retrospective Analysis of Prismaflex HF20 Set Versus ppCRRT Registry

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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Key information

Conditions

Acute Renal Failure (ARF) Acute Kidney Injury Acute Kidney Injury (AKI) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fluid Overload in Dialysis Patients Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham / Children's of Alabama, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient weighed between 8 and 20 kg (17.6 - 44.1 lb).
  • Patient received medical care in an intensive care unit (ICU) and was treated with HF20 based CRRT.
  • 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.

Treatment and study plan

Prismaflex HF20

Device

CRRT fluid management and reduction of uremic toxins.

Primary outcomes

  1. Survival to CRRT discontinuation

    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)

    The proportion of patients who completed HF20/M60 based CRRT

  2. Survival to ICU discharge

    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)

    The proportion of patients who were released from the ICU

Secondary outcomes

  1. ICU length of stay

    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)

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

  2. CRRT duration

    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)

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

  3. AEs of relevance for HF20

    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)

    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).

Sponsors and collaborators

Lead sponsor

Vantive Health LLC

Industry

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study title

Comparison of Patient Outcomes Between Retrospective Prismaflex HF20 Set and Historical Prospective Pediatric Continuous Renal Replacement Therapy (ppCRRT) Registry

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 9, 2024
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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