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

NCT ID: NCT03473769

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-06-30

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.

Conditions

Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Vital Signs at 2 Hours + CAM-ICU

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

Group Type: EXPERIMENTAL

Vital Signs at 2 Hours

Intervention Type: OTHER

Patients vital signs assessed at 2 hours of arrival at ICU

Confusion Assessment method for the ICU (CAM-ICU)

Intervention Type: OTHER

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.

No Intervention

No intervention. Patient treated per standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vital Signs at 2 Hours

Patients vital signs assessed at 2 hours of arrival at ICU

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• any inpatient at NYU Langone Health System

Exclusion Criteria

• not an inpatient at NYU Langone Health System

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Nunnally, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

17-01565

Identifier Type: -

Identifier Source: org_study_id