NCT00698542

Brief Summary

The Patient Safety Screening Tool (PSST) for Sepsis solution is a tool to assist with the early detection of Sepsis and management of the administration of bundle packages as defined by the Institute for Healthcare Improvement (IHI). This web based application relies on integration with bedside medical equipment (BME) data as well as Lab and Registration data so that clinical workflow items can be automated in the fight against Sepsis.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
221

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

May 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

1.8 years

First QC Date

June 12, 2008

Last Update Submit

April 19, 2017

Conditions

Keywords

PSSTsepsisNeuro Care UnitSurviving Sepsis CampaignSSC

Outcome Measures

Primary Outcomes (1)

  • Demonstrate a reduction in time to detection of sepsis using the PSST Alert System

    6 and 24 hours

Secondary Outcomes (1)

  • Determine the accuracy of the PSST Alert System

    6 and 24 hours

Study Arms (1)

1

Patients in the NCU at VUH

Eligibility Criteria

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

This study will be located in the 22 bed Vanderbilt University Medical Center Neuro Care Unit (NCU). Every patient will be screened for sepsis according to the following workflow upon admission to the NCU. The patient population of the NCU is generally bimodal; the first group consists of post-operative patients with an average length of stay of three to five days. The second group consists of subarachnoid hemorrhage patients with an average length of stay of 45 days.

You may qualify if:

  • Patients that are hospitalized in the Neuro Care Unit (NCU)
  • Patients that are hospitalized in the Vanderbilt Burn Center
  • Patients must be \> 18 years of age

You may not qualify if:

  • Patients \< 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Links

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • John A Barwise, M.D.

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asssistant Professor

Study Record Dates

First Submitted

June 12, 2008

First Posted

June 17, 2008

Study Start

May 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

April 20, 2017

Record last verified: 2017-04

Locations