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Subclinical Delirium and Clinical Outcome (ZZH-2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01616914
First Posted: June 12, 2012
Last Update Posted: April 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zhongheng Zhang, Jinhua Central Hospital
  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:


Further study details as provided by Zhongheng Zhang, Jinhua Central Hospital:

Primary Outcome Measures:
  • mortality [ Time Frame: during hospital stay(60 days) ]
    60 days after enrollment


Secondary Outcome Measures:
  • duration of mechanical ventilation [ Time Frame: 60 days ]
  • length of stay in ICU and hospital [ Time Frame: 60 days after enrollment ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Zhongheng Zhang, Jinhua central hospital, Jinhua Central Hospital
ClinicalTrials.gov Identifier: NCT01616914     History of Changes
Other Study ID Numbers: ZZH-2
First Submitted: June 7, 2012
First Posted: June 12, 2012
Last Update Posted: April 4, 2013
Last Verified: June 2012

Keywords provided by Zhongheng Zhang, Jinhua Central Hospital:
delirium
outcome

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders