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Subclinical Delirium and Clinical Outcome (ZZH-2)

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.
 
ClinicalTrials.gov Identifier: NCT01616914
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):
Zhongheng Zhang, Jinhua Central Hospital

Tracking Information
First Submitted Date June 7, 2012
First Posted Date June 12, 2012
Last Update Posted Date April 4, 2013
Study Start Date January 2010
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 11, 2012)
mortality [ Time Frame: during hospital stay(60 days) ]
60 days after enrollment
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 11, 2012)
  • duration of mechanical ventilation [ Time Frame: 60 days ]
  • length of stay in ICU and hospital [ Time Frame: 60 days after enrollment ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Subclinical Delirium and Clinical Outcome
Official Title Delirium and Clinical Outcome
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients enter ICU GCS > 10 RASS > -2 No dementia
Condition Delirium
Intervention Not Provided
Study Groups/Cohorts
  • delirium group
    patients with delirium during ICU stay
  • non-delirium group
    patients without delirium during ICU stay
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 11, 2012)
250
Original Estimated Enrollment Same as current
Actual Study Completion Date August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • unable to cooperate
  • coma
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01616914
Other Study ID Numbers ZZH-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Zhongheng Zhang, Jinhua Central Hospital
Study Sponsor Jinhua Central Hospital
Collaborators Not Provided
Investigators
Study Chair: Zhongheng Zhang, MM Jinhua Central Hospital
PRS Account Jinhua Central Hospital
Verification Date June 2012