NCT00998387

Brief Summary

The purpose of this study is to translate and validate the CAM-ICU for use in the Korean ICU setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2009

Completed
Last Updated

October 20, 2009

Status Verified

October 1, 2009

Enrollment Period

8 months

First QC Date

October 16, 2009

Last Update Submit

October 17, 2009

Conditions

Critical Care

Outcome Measures

Primary Outcomes (3)

  • Interrater reliability of Korean CAM-ICU

    after completion of study

  • Sensitivity of Korean CAM-ICU for diagnosing ICU delirium

    after completion of study

  • Specificity of Korean CAM-ICU for diagnosing ICU delirium

    after completion of study

Study Arms (1)

medical ICU

admitted to medical ICU at Seoul National University Hospital longer than 24 hours

Eligibility Criteria

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

Patients admitted to medical ICU at Seoul National University Hospital longer than 24 hours

You may qualify if:

  • older than 18 years
  • admitted to medical ICU at Seoul National University Hospital longer than 24 hours

You may not qualify if:

  • comatose or moribund state throughout the study period
  • preexisting neurologic problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Study Officials

  • Sang Min Lee, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 16, 2009

First Posted

October 20, 2009

Study Start

July 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

October 20, 2009

Record last verified: 2009-10

Locations

KR(1)