Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06037109
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2023-09-07
Brief Title:
VIDAS NEPHROCLEAR Reference Interval Study
Sponsor:
BioMérieux
Organization:
BioMérieux
Study Overview
Official Title:
VIDAS NEPHROCLEAR CCL14 Reference Interval Study
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center sample analysis study in which urine samples previously collected from apparently healthy adult subjects and subjects with stable chronic morbidities but without AKI in order to establish the reference range for the VIDAS NEPHROCLEAR CCL14 test
Detailed Description:
The VIDAS NEPHROCLEAR CCL14 Test is intended to be used in conjunction with clinical evaluation in ICU patients with moderate to severe stage 2 or 3 acute kidney injury AKI as an aid in the risk assessment for developing persistent severe AKI stage 3 AKI lasting 72 hours within 48 hours of patient assessment
The VIDAS NEPHROCLEAR CCL14 Test is intended to be used in patients 21 years of age or older
The objective of this study is to determine the reference range for CCL14 concentration in Apparently Healthy Adults and Adults with Chronic Stable Morbidities
The VIDAS NEPHROCLEAR CCL14 Test is intended to be used in patients 21 years of age or older
The objective of this study is to determine the reference range for CCL14 concentration in Apparently Healthy Adults and Adults with Chronic Stable Morbidities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None