ICU MortalityECOGNCT02386254
Adaptation of a Premorbid Function Scoring System as a Predictor for Intensive Care Unit Mortality
An observational study of ICU Mortality and ICU Morbidity, run by University of Oklahoma at 1 site in United States.
Trial summary
To evaluate whether a premorbid functioning scoring system such as the ECOG system can be adapted to predict ICU morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Mortality, ICU Morbidity
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2018to 18 Nov 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the critical care units of Presbyterian Hospital under the care of the medical ICU service with any diagnosis will be assessed for enrollment.
Who may be able to join
- All patients aged 18 years and older admitted to the Presbyterian Hospital intensive care units under the medical ICU service.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate whether a premorbid functioning scoring system such as the ECOG system can be adapted to predict ICU morbidity and mortality.
- Conditions
- ICU Mortality, ICU Morbidity
- Keywords
- premorbid, scoring system, ECOG, ICU, morbidity, mortality
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Data will be expressed as mean + SD. Non parametric data will be expressed as median with interquartiles. Student t-test will be used to compare the normally distributed data, and the Mann-Whitney U test will be used for non parametric data. Chi-Squared test will be used to assess for trend between the ECOG score and the 30-day mortality. The investigators will use logistic regression analysis to determine the factors (including the ECOG score) associated with the 30-day mortality. Significance will be accepted for p values < 0.05.
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study start26 Nov 2018
- Primary completion18 Nov 2019
- Study completion18 Nov 2019
Why it stopped: The study was administratively inactivated by the IRB after the PI did not submit the annual review and did not respond to the IRB's expiration letters.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU MortalityStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kellie Jones, MD, Principal investigator, Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386254
- Sponsor's protocol ID
- ECOG 9058
- Acronym
- ECOG
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2015
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of a Premorbid Function Scoring System as a Predictor for Intensive Care Unit Mortality
- ClinicalTrials.gov ID
- NCT02386254
- Acronym / sponsor ID
- ECOG / ECOG 9058
- Conditions
- ICU Mortality, ICU Morbidity
- Keywords
- premorbid, scoring system, ECOG, ICU, morbidity, mortality
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was administratively inactivated by the IRB after the PI did not submit the annual review and did not respond to the IRB's expiration letters.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 18 Nov 2019 (actual)
- Study completion
- 18 Nov 2019 (actual)
- First posted
- 11 Mar 2015 (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.
To evaluate whether a premorbid functioning scoring system such as the ECOG system can be adapted to predict ICU morbidity and mortality.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the critical care units of Presbyterian Hospital under the care of the medical ICU service with any diagnosis will be assessed for enrollment.
Key inclusion criteria (1 listed)
- All patients aged 18 years and older admitted to the Presbyterian Hospital intensive care units under the medical ICU service.
Key exclusion criteria (1 listed)
- -
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
Mortality
Time frame: 30-day
Data will be expressed as mean + SD. Non parametric data will be expressed as median with interquartiles. Student t-test will be used to compare the normally distributed data, and the Mann-Whitney U test will be used for non parametric data. Chi-Squared test will be used to assess for trend between the ECOG score and the 30-day mortality. The investigators will use logistic regression analysis to determine the factors (including the ECOG score) associated with the 30-day mortality. Significance will be accepted for p values < 0.05.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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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.
Kellie Jones, MD principal investigator
Faculty
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 ICU Mortality and ICU Morbidity, run by University of Oklahoma 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 12 Mar 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
Mortality (time frame: 30-day). 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 Mar 2024.