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

NCT03473769 | Withdrawn

• 1 other identifier: 17-01565
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

Hospital Admission

Outcome Measures

Primary Outcomes (1)

• Number of in-hospital mortalities

  36 Months

Study Arms (2)

Vital Signs at 2 Hours + CAM-ICU

EXPERIMENTAL

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

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

No Intervention

NO INTERVENTION

No intervention. Patient treated per standard of care.

Interventions

Vital Signs at 2 Hours OTHER

Patients vital signs assessed at 2 hours of arrival at ICU

Vital Signs at 2 Hours + CAM-ICU

Confusion Assessment method for the ICU (CAM-ICU) 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.

Vital Signs at 2 Hours + CAM-ICU

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• any inpatient at NYU Langone Health System

You may not qualify if:

• not an inpatient at NYU Langone Health System

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Nunnally, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: March 22, 2018
• Study Start: September 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)