NCT01616914

Brief Summary

Delirium has been associated with clinical outcomes in critical care setting. However, its subclinical form has not been investigated. The investigators aimed to establish the association of subclinical delirium with outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Typical duration 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

January 1, 2010

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

April 4, 2013

Status Verified

June 1, 2012

Enrollment Period

2.6 years

First QC Date

June 7, 2012

Last Update Submit

April 1, 2013

Conditions

Keywords

deliriumoutcome

Outcome Measures

Primary Outcomes (1)

  • mortality

    60 days after enrollment

    during hospital stay(60 days)

Secondary Outcomes (2)

  • duration of mechanical ventilation

    60 days

  • length of stay in ICU and hospital

    60 days after enrollment

Study Arms (2)

delirium group

patients with delirium during ICU stay

non-delirium group

patients without delirium during ICU stay

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients enter ICU GCS \> 10 RASS \> -2 No dementia

You may qualify if:

  • patients enter ICU
  • GCS \> 10
  • RASS \> -2

You may not qualify if:

  • unable to cooperate
  • coma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinhua central hospital

Jinhua, Zhejiang, 321000, China

Location

Related Publications (3)

  • van den Boogaard M, Pickkers P, Slooter AJ, Kuiper MA, Spronk PE, van der Voort PH, van der Hoeven JG, Donders R, van Achterberg T, Schoonhoven L. Development and validation of PRE-DELIRIC (PREdiction of DELIRium in ICu patients) delirium prediction model for intensive care patients: observational multicentre study. BMJ. 2012 Feb 9;344:e420. doi: 10.1136/bmj.e420.

    PMID: 22323509BACKGROUND
  • van den Boogaard M, Schoonhoven L, van der Hoeven JG, van Achterberg T, Pickkers P. Incidence and short-term consequences of delirium in critically ill patients: A prospective observational cohort study. Int J Nurs Stud. 2012 Jul;49(7):775-83. doi: 10.1016/j.ijnurstu.2011.11.016. Epub 2011 Dec 22.

    PMID: 22197051BACKGROUND
  • Tomasi CD, Grandi C, Salluh J, Soares M, Giombelli VR, Cascaes S, Macedo RC, de Souza Constantino L, Biff D, Ritter C, Dal Pizzol F. Comparison of CAM-ICU and ICDSC for the detection of delirium in critically ill patients focusing on relevant clinical outcomes. J Crit Care. 2012 Apr;27(2):212-7. doi: 10.1016/j.jcrc.2011.05.015. Epub 2011 Jul 6.

    PMID: 21737237BACKGROUND

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Zhongheng Zhang, MM

    Jinhua Central Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jinhua central hospital

Study Record Dates

First Submitted

June 7, 2012

First Posted

June 12, 2012

Study Start

January 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

April 4, 2013

Record last verified: 2012-06

Locations