NCT00591955

Brief Summary

The purpose of this study is to determine factors which predict a complicated hospital course and then to develop from these findings an Emergency Department guideline to assist in knowing who is at highest risk of elderly patients with infection presenting for care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
213

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

July 12, 2013

Status Verified

July 1, 2013

Enrollment Period

2.8 years

First QC Date

December 26, 2007

Last Update Submit

July 11, 2013

Conditions

Sepsis

Keywords

geriatricsepsisoutcome assessment(healthcare)

Outcome Measures

Primary Outcomes (1)

  • Complicated Clinical course

    The presense of any one of the following will constitute a complicated clinical course: 1. mortality at 30 days 2. requirement for ICU admission or ICU-level care withing first 48 hours 3. positive blood cultures

    0-30 days from ED visit

Secondary Outcomes (1)

  • Inadequate process of care

    entire length of Emergency Department visit and hospitalization

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 65 or older who present to the Emergency Department with signs that could be consistent with infection

You may qualify if:

  • age 65 or older
  • blood cultures ordered in the Emergency Department
  • admitted to the hospital from the Emergency Department

You may not qualify if:

  • age less than 65
  • prisoners
  • Patient unable to provide consent and no legally authorized representative available
  • non-English speaking
  • ED visit or admission in the last 7 days for the same condition
  • primary evaluation by the trauma team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeffrey M Caterino, MD

    The Ohio State University Department of Emergency Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 11, 2008

Study Start

January 1, 2006

Primary Completion

October 1, 2008

Study Completion

September 1, 2009

Last Updated

July 12, 2013

Record last verified: 2013-07

Locations

US(1)