Subclinical Delirium and Clinical Outcome

Delirium Clinical Trial

— ZZH-2  

Official title:

Delirium and Clinical Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616914
• Other study ID #: ZZH-2
• Status: Completed
• Phase: N/A
• First received: June 7, 2012
• Last updated: April 1, 2013
• Start date: January 2010
• Est. completion date: August 2012

Study information

• Verified date: June 2012
• Source: Jinhua Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

Delirium has been associated with clinical outcome in critical care setting. This syndrome has been associated with longer length of stay in ICU and hospital, longer duration of mechanical ventilation and higher mortality rate. however, its subclinical form has not been investigated. The subclinical syndrome is defined by CAM-ICU, in which several features of delirium are fulfilled but the diagnostic criteria are not fulfilled. The investigators aimed to establish the association of subclinical delirium with outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients enter ICU

• GCS > 10

• RASS > -2

Exclusion Criteria:

• unable to cooperate

• coma

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Delirium

Locations

Country	Name	City	State
China	Jinhua central hospital	Jinhua	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Jinhua Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	60 days after enrollment	during hospital stay(60 days)	Yes
Secondary	duration of mechanical ventilation		60 days	Yes
Secondary	length of stay in ICU and hospital		60 days after enrollment	Yes