Back to resultsSepsis Pre-Alert Monitoring Intervention: Study to Investigate Targeted Enhanced Monitoring for Sepsis
Primary Purpose
Sepsis
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vital Signs at 2 Hours
Confusion Assessment method for the ICU (CAM-ICU)
Sponsored by
About this trial
This is an interventional prevention trial for Sepsis focused on measuring Hospital Admission
Eligibility Criteria
Inclusion Criteria:
- any inpatient at NYU Langone Health System
Exclusion Criteria:
- not an inpatient at NYU Langone Health System
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Vital Signs at 2 Hours + CAM-ICU
No Intervention
Arm Description
enhanced vital sign and delirium monitoring in patients for who the per-sepsis algorithm reaches alert threshold.
No intervention. Patient treated per standard of care.
Outcomes
Primary Outcome Measures
Number of in-hospital mortalities
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03473769
Brief Title
Sepsis Pre-Alert Monitoring Intervention: Study to Investigate Targeted Enhanced Monitoring for Sepsis
Official Title
Sepsis Pre-Alert Monitoring Intervention: A Phase I Randomized, Single Blind Study to Investigate Targeted Enhanced Monitoring for Sepsis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
Hospital Admission
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
7500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vital Signs at 2 Hours + CAM-ICU
Arm Type
Experimental
Arm Description
enhanced vital sign and delirium monitoring in patients for who the per-sepsis algorithm reaches alert threshold.
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
No intervention. Patient treated per standard of care.
Intervention Type
Other
Intervention Name(s)
Vital Signs at 2 Hours
Intervention Description
Patients vital signs assessed at 2 hours of arrival at ICU
Intervention Type
Other
Intervention Name(s)
Confusion Assessment method for the ICU (CAM-ICU)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of in-hospital mortalities
Time Frame
36 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
any inpatient at NYU Langone Health System
Exclusion Criteria:
not an inpatient at NYU Langone Health System
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Germaine Cuff
Phone
646 501 2320
Email
germaine.cuff@nyumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Nunnally, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Germaine Cuff
Phone
646-501-2320
Email
germaine.cuff@nyumc.org
First Name & Middle Initial & Last Name & Degree
Mark Nunnally, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sepsis Pre-Alert Monitoring Intervention: Study to Investigate Targeted Enhanced Monitoring for Sepsis
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