Sepsis Pre-Alert Monitoring Intervention: Study to Investigate Targeted Enhanced Monitoring for Sepsis

Not Applicable

Withdrawn

• Conditions: Sepsis
• Interventions: Other: Vital Signs at 2 Hours; Other: Confusion Assessment method for the ICU (CAM-ICU)

• Registration Number: NCT03473769
• Lead Sponsor: NYU Langone Health

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.

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 Timeline

• Study First Submitted: 2018-03-16
• Study First Submitted QC: 2018-03-21
• Study First Posted: 2018-03-22
• Study Start: 2024-09-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 7500

Inclusion Criteria

• any inpatient at NYU Langone Health System

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Exclusion Criteria

• not an inpatient at NYU Langone Health System

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vital Signs at 2 Hours + CAM-ICU	Confusion Assessment method for the ICU (CAM-ICU)	enhanced vital sign and delirium monitoring in patients for who the per-sepsis algorithm reaches alert threshold.
Vital Signs at 2 Hours + CAM-ICU	Vital Signs at 2 Hours	enhanced vital sign and delirium monitoring in patients for who the per-sepsis algorithm reaches alert threshold.

Primary Outcome Measures

Name	Time	Method
Number of in-hospital mortalities	36 Months

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States