Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT04570618
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
2020-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Prediction of Sepsis
Sponsor:
AlgoDx
Organization:
Study Overview
Official Title:
Early Prediction of Sepsis in Hospitalized Patients Using a Machine Learning Algorithm, a Randomized Clinical Validation Trial.
Status:
COMPLETED
Status Verified Date:
2021-11
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:
ExPRESS
Brief Summary:
In this clinical trial a novel Medical Device Software will be validated prospectively. The software incorporates a machine learning algorithm capable of predicting sepsis by using routine clinical variables in adult patients at Intensive Care Units.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: