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

NYU Langone Health

Status: Withdrawn

Conditions: Sepsis

Treatments: Other: Confusion Assessment method for the ICU (CAM-ICU); Other: Vital Signs at 2 Hours

Study type: Interventional

Funder types: Other

Identifiers

NCT03473769

17-01565

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• any inpatient at NYU Langone Health System

Exclusion criteria

• not an inpatient at NYU Langone Health System

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Vital Signs at 2 Hours + CAM-ICU

Experimental group

Description:

enhanced vital sign and delirium monitoring in patients for who the per-sepsis algorithm reaches alert threshold.

Treatment:

Other: Vital Signs at 2 Hours

Other: Confusion Assessment method for the ICU (CAM-ICU)

No Intervention

No Intervention group

Description:

No intervention. Patient treated per standard of care.