NCT06633029

Retrospective Analysis of Prismaflex HF20 Set Versus ppCRRT Registry

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 59 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Prismaflex HF20	CRRT fluid management and reduction of uremic toxins.

Timeline

• Start date: 2024-12-11
• Primary completion: 2025-06-25
• Completion: 2025-06-25
• First posted: 2024-10-09
• Last updated: 2026-02-17

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study