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Risk Factors for Delirium in Critically Ill Surgical Patients

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: 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

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.

Condition or disease
Delirium Intensive Care Unit Syndrome

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.

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Study Type : Observational
Actual Enrollment : 251 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk Factors for Delirium in Critically Ill Surgical Patients
Actual Study Start Date : April 1, 2013
Actual Primary Completion Date : August 30, 2013
Actual Study Completion Date : August 30, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Group/Cohort
Delirium positive
delirium patients in critically ill surgical patients
Delirium negative
non delirium patients in critically ill surgical patients



Primary Outcome Measures :
  1. Prevelance of delirium [ Time Frame: with in 6month in SICU ]
    Analyses were performed to delirium prevelance of SICU Patients


Secondary Outcome Measures :
  1. Risk factors associated with delirium [ Time Frame: with in 6month in SICU ]
    Analyses were performed to compare patient, disease, treatment and environment-related factors



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

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): NCT03050021


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 05505
Sponsors and Collaborators
Suk-Kyung
Investigators
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Principal Investigator: Suk-kyung Hong, Ph.D University of Ulsan College of Medicine. Asan Medical Center
Publications of Results:

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Responsible Party: Suk-Kyung, Associate Professor in General Surgery, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03050021    
Other Study ID Numbers: 2014-0251
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suk-Kyung, Asan Medical Center:
Delirium
Intensive care unit
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders