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OpenTrials
Completed

NCT Number: NCT00591955

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

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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:

    • mortality at 30 days
    • requirement for ICU admission or ICU-level care withing first 48 hours
    • positive blood cultures

Secondary outcomes

  1. 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:

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

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Jan 11, 2008
Registry last updated
Jul 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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