SepsisNCT00591955
Infected Elders in the Emergency Department: Outcomes and Processes of Care
An observational study of Sepsis, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sepsis
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 65 or older who present to the Emergency Department with signs that could be consistent with infection
Who may be able to join
- age 65 or older
- blood cultures ordered in the Emergency Department
- admitted to the hospital from the Emergency Department
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
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.
Read the 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.
- Conditions
- Sepsis
- Keywords
- geriatric, sepsis, outcome assessment(healthcare)
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Complicated Clinical course
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
Measured: 0-30 days from ED visit
Secondary outcomes (1)
Inadequate process of care
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
Measured: entire length of Emergency Department visit and hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startJan 2006
- Primary completionOct 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Caterino, Ohio State University
- Investigators
- Jeffrey M Caterino, MD, Principal investigator, The Ohio State University Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591955
- Sponsor's protocol ID
- 2005H0206
- Status last verified
- Jul 2013
- First submitted
- 26 Dec 2007
- Last updated
- 12 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infected Elders in the Emergency Department: Outcomes and Processes of Care
- ClinicalTrials.gov ID
- NCT00591955
- Acronym / sponsor ID
- 2005H0206
- Conditions
- Sepsis
- Keywords
- geriatric, sepsis, outcome assessment(healthcare)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 or older who present to the Emergency Department with signs that could be consistent with infection
Key inclusion criteria (3 listed)
- age 65 or older
- blood cultures ordered in the Emergency Department
- admitted to the hospital from the Emergency Department
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Inadequate process of care
Time frame: entire length of Emergency Department visit and hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey M Caterino, MD principal investigator
The Ohio State University Department of Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complicated Clinical course (time frame: 0-30 days from ED visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2013.