Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT03473769
Status:
WITHDRAWN
Last Update Posted:
2024-10-09
First Post:
2018-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sepsis Pre-Alert Monitoring Intervention: Study to Investigate Targeted Enhanced Monitoring for Sepsis
Sponsor:
NYU Langone Health
Organization:
Study Overview
Official Title:
Sepsis Pre-Alert Monitoring Intervention: A Phase I Randomized, Single Blind Study to Investigate Targeted Enhanced Monitoring for Sepsis
Status:
WITHDRAWN
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to develop formula for data collection
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sepsis is a leading cause of death worldwide, and contributes to approximately 750,000 hospitalizations per year, a third of which may die. International guidelines recommend timely interventions, including cultures, fluid resuscitation and antibiotics. Following guideline bundles is associated with a decrease in mortality. Key to timely intervention is timely diagnosis.
Using the Epic sepsis predictive analytic tool, investigators will trigger vital sign and delirium monitoring in patients determined to be at increased risk for developing future sepsis.
The primary objective of this study is to demonstrate reduced mortality in patients for whom the pre-sepsis algorithm threshold is met, and who enhanced monitoring.
Using the Epic sepsis predictive analytic tool, investigators will trigger vital sign and delirium monitoring in patients determined to be at increased risk for developing future sepsis.
The primary objective of this study is to demonstrate reduced mortality in patients for whom the pre-sepsis algorithm threshold is met, and who enhanced monitoring.
Detailed Description:
A means to identify patients before they become ill may improve the effectiveness of established therapies.Epic's electronic medical record (Epic systems, Verona, WI) contains a surveillance tool that uses predictive analytics to identify patients at risk of becoming septic four hours after the alert becomes active. This affords the opportunity to intervene sooner, but it remains unclear what the best course of action should be in a population at risk of sepsis, only some of which may go on to develop the illness. We propose an automatic intervention, consisting of enhanced monitoring, that is tied to the alert. No therapeutics will be mandated. Instead, additional monitoring information will lead to faster diagnosis and therapy, and improved clinical outcomes.
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?: