NCT03473769

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

Sepsis Pre-Alert Monitoring Intervention: A Phase I Randomized, Single Blind Study to Investigate Targeted Enhanced Monitoring for Sepsis

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis

Interventions

Type	Name	Description
OTHER	Vital Signs at 2 Hours	Patients vital signs assessed at 2 hours of arrival at ICU
OTHER	Confusion Assessment method for the ICU (CAM-ICU)	patient must have altered mental status/fluctuating course and inattention, and either disorganized thinking or altered level of consciousness to be CAM positive; these features are determined by observing the patient during bedside cognitive testing.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2018-03-22
• Last updated: 2024-10-09

Locations

1 site across 1 country: United States