NCT02386254

Brief Summary

To evaluate whether a premorbid functioning scoring system such as the ECOG system can be adapted to predict ICU morbidity and mortality.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

March 5, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
3.7 years until next milestone

Study Start

First participant enrolled

November 26, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2019

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

12 months

First QC Date

March 5, 2015

Last Update Submit

March 7, 2024

Conditions

Keywords

premorbidscoring systemECOGICUmorbiditymortality

Outcome Measures

Primary Outcomes (1)

  • 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.

    30-day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • All patients aged 18 years and older admitted to the Presbyterian Hospital intensive care units under the medical ICU service.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Study Officials

  • Kellie Jones, MD

    Faculty

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2015

First Posted

March 11, 2015

Study Start

November 26, 2018

Primary Completion

November 18, 2019

Study Completion

November 18, 2019

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations