NCT01505478

Brief Summary

The investigators will conduct a prospective cohort study to compare an automated sepsis severity score to a conventional clinical prediction rule to risk stratify patients admitted from the emergency department (ED) with suspected infection for 28 day in-hospital mortality.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
Last Updated

April 5, 2017

Status Verified

January 1, 2012

First QC Date

January 4, 2012

Last Update Submit

April 4, 2017

Conditions

Sepsis

Keywords

SepsisClinical Prediction RuleClinical InformaticsMachine Learning

Outcome Measures

Primary Outcomes (1)

  • 28 day in-hospital mortality

    The primary endpoint is the AUC of a model to predict 28 day all cause in-hospital mortality. Patients discharged or transferred to another hospital before 28 days will be assumed to be alive at 28 days.

Secondary Outcomes (1)

  • ICU Admission

Study Arms (1)

Patients admitted with infection

All consecutive ED patients during the study period that have been admitted and identified to have a suspected infection at ED disposition using a data collection tool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted from the Emergency Department with suspected infection.

You may qualify if:

  • All consecutive adult (age 18 or older) Emergency Department (ED) patients during the study period that have been admitted from the ED and identified by the treating clinician to have a suspected infection at the time of ED disposition will comprise our study population.

You may not qualify if:

  • No patients will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Steven Horng, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor in Emergency Medicine

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 6, 2012

Study Start

July 1, 2012

Last Updated

April 5, 2017

Record last verified: 2012-01

Locations

US(1)