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Infected Elders in the Emergency Department: Outcomes and Processes of Care

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00591955
First Posted: January 11, 2008
Last Update Posted: July 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jeffrey Caterino, Ohio State University
  Purpose
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.

Condition
Sepsis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Infected Elders in the Emergency Department: Outcomes and Processes of Care

Resource links provided by NLM:


Further study details as provided by Jeffrey Caterino, Ohio State University:

Primary Outcome Measures:
  • Complicated Clinical course [ Time Frame: 0-30 days from ED visit ]

    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


Secondary Outcome Measures:
  • Inadequate process of care [ Time Frame: entire length of Emergency Department visit and hospitalization ]

    failure to meet any one of the following will be considered inadequate processes of care:

    1. obtain blood cultures prior to antibiotic administration
    2. administration of antibiotics within 4 hours of presentation
    3. measure serum lactate if patient has severe sepsis in the ED
    4. Fluid resuscitation of 20-40cc/kg if mean arterial perssure is <65mmHg despite fluid resuscitation


Enrollment: 213
Study Start Date: January 2006
Study Completion Date: September 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Detailed Description:
The study is looking at how closely physicians adhere to treatment guidelines in caring for elderly patients, and then to determine if there are differences in elderly patient disease symptoms that result in a failure to use guidelines. If this is known, physicians can then be aware of these differences and provide appropriate care.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 65 or older who present to the Emergency Department with signs that could be consistent with infection
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591955


Locations
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Jeffrey M Caterino, MD The Ohio State University Department of Emergency Medicine
  More Information

Responsible Party: Jeffrey Caterino, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT00591955     History of Changes
Other Study ID Numbers: 2005H0206
First Submitted: December 26, 2007
First Posted: January 11, 2008
Last Update Posted: July 12, 2013
Last Verified: July 2013

Keywords provided by Jeffrey Caterino, Ohio State University:
geriatric
sepsis
outcome assessment(healthcare)

Additional relevant MeSH terms:
Emergencies
Sepsis
Disease Attributes
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation