Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633029
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Retrospective Analysis of Prismaflex HF20 Set Versus ppCRRT Registry
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Patient Outcomes Between Retrospective Prismaflex HF20 Set and Historical Prospective Pediatric Continuous Renal Replacement Therapy ppCRRT Registry
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 registrys primary outcome measure was patient survival to ICU discharge
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 registrys primary outcome measure was patient survival to ICU discharge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None