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Risk Factors for Delirium in Critically Ill Surgical Patients

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ClinicalTrials.gov Identifier: NCT03050021
Recruitment Status : Completed
First Posted : February 10, 2017
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Suk-Kyung, Asan Medical Center

Tracking Information
First Submitted Date February 8, 2017
First Posted Date February 10, 2017
Last Update Posted Date February 10, 2017
Actual Study Start Date April 1, 2013
Actual Primary Completion Date August 30, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 8, 2017)
Prevelance of delirium [ Time Frame: with in 6month in SICU ]
Analyses were performed to delirium prevelance of SICU Patients
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 8, 2017)
Risk factors associated with delirium [ Time Frame: with in 6month in SICU ]
Analyses were performed to compare patient, disease, treatment and environment-related factors
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 Risk Factors for Delirium in Critically Ill Surgical Patients
Official Title Risk Factors for Delirium in Critically Ill Surgical Patients
Brief Summary Delirium is characterized by changes in mental status, inattension, disorganized thinking, and altered consciousness. Prevalence of delirium in critically ill patients has varied from 20~80% depending on the severity of illness. Despite its high prevalence, delirium is often under-recognized by clinicians due to the difficulties in diagnosis and no interest. Delirium is associated with increased mechanical ventilation days, hospital length of stay, and mortality. The purpose of this study is to analyze the prevalence of delirium and risk factors for delirium in critically ill surgical patients.
Detailed Description

The investigators performed a prospective cohort study involving the patients admitted to surgical ICU between april 2013 and august 2013.

The included patients were assessed independently by trained ICU nurses using the confusion Assessment Method for the ICU (CAM-ICU). The patients were recorded general characteristics, disease-related factors, and treatment and environment-related factors. Data were analyzed by SPSS 12.0 software, using t-test, Fisher's exact test and logistic regression.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Admitted to the surgical ICU from April to August 2013 and had the ability to express themselves verbally or nonverbally.
Condition
  • Delirium
  • Intensive Care Unit Syndrome
Intervention Not Provided
Study Groups/Cohorts
  • Delirium positive
    delirium patients in critically ill surgical patients
  • Delirium negative
    non delirium patients in critically ill surgical patients
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: February 8, 2017)
251
Original Actual Enrollment Same as current
Actual Study Completion Date August 30, 2015
Actual Primary Completion Date August 30, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Above RASS -3 paitent
  2. Verbally or nonverbally communication possible patients

Exclusion Criteria:

  1. Under age 18
  2. Neurological disorder e.g.) Brain injury, dementia and traumatic brain injury
  3. Readmitted to ICU
  4. History of delirium
  5. Transplanted; isolation is required
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03050021
Other Study ID Numbers 2014-0251
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Suk-Kyung, Asan Medical Center
Study Sponsor Suk-Kyung
Collaborators Not Provided
Investigators
Principal Investigator: Suk-kyung Hong, Ph.D University of Ulsan College of Medicine. Asan Medical Center
PRS Account Asan Medical Center
Verification Date February 2017