Subclinical Delirium and Clinical Outcome (ZZH-2)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Zhongheng Zhang, Jinhua Central Hospital

ClinicalTrials.gov Identifier:

NCT01616914

First received: June 7, 2012

Last updated: April 1, 2013

Last verified: June 2012

History of Changes

Purpose

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.

Condition
Delirium

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Delirium and Clinical Outcome

Resource links provided by NLM:

MedlinePlus related topics: Delirium

U.S. FDA Resources

Further study details as provided by Jinhua Central Hospital:

Primary Outcome Measures:

mortality [ Time Frame: during hospital stay(60 days) ] [ Designated as safety issue: Yes ]
60 days after enrollment

Secondary Outcome Measures:

duration of mechanical ventilation [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
length of stay in ICU and hospital [ Time Frame: 60 days after enrollment ] [ Designated as safety issue: Yes ]

Enrollment:	250
Study Start Date:	January 2010
Study Completion Date:	August 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
delirium group patients with delirium during ICU stay
non-delirium group patients without delirium during ICU stay

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

patients enter ICU
GCS > 10
RASS > -2

Exclusion Criteria:

unable to cooperate
coma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616914

Locations

China, Zhejiang
Jinhua central hospital
Jinhua, Zhejiang, China, 321000

Sponsors and Collaborators

Jinhua Central Hospital

Investigators

Study Chair:

Zhongheng Zhang, MM

Jinhua Central Hospital

More Information

Publications:

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. 2011 Dec 22. [Epub ahead of print]

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. Epub 2011 Jul 6.

Responsible Party:	Zhongheng Zhang, Jinhua central hospital, Jinhua Central Hospital
ClinicalTrials.gov Identifier:	NCT01616914 History of Changes
Other Study ID Numbers:	ZZH-2
Study First Received:	June 7, 2012
Last Updated:	April 1, 2013
Health Authority:	China: Food and Drug Administration

Keywords provided by Jinhua Central Hospital:

delirium
outcome

Additional relevant MeSH terms:

Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations

Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013

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