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Clinical Trials/NCT03023839
NCT03023839
Completed
Not Applicable

Incidence and Risk Factors for Delirium in Severely Injured Patients

Asan Medical Center1 site in 1 country179 target enrollmentFebruary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium
Sponsor
Asan Medical Center
Enrollment
179
Locations
1
Primary Endpoint
Incidence of delirium in trauma patients
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Delirium is very common in intensive care unit (ICU) patients and leads to poor outcomes. There is little information on delirium in injured patients however. This study determined the incidence and risk factors for delirium in severely injured patients.

Detailed Description

This study was a prospective cohort study that reviewed the medical records of 179 trauma patients who were admitted to Asan Medical Center from January 01, 2013 to December 31, 2014. The investigators included all patients who had an Injury Severity Score (ISS) of more than 15 and excluded patients younger than 15 years old. This study was approved by the Asan Medical Center Institutional Review Board (2014-0344). Patient delirium was checked using the Confusion Assessment Method in Intensive Care Unit (CAM-ICU) three times every day. The CAM-ICU includes four features that assess acute changes in or the fluctuating course of mental status, inattention, altered level of consciousness, and disorganized thinking. If a patient has a Richmond Agitation Sedation Scale (RASS) score of -3 or more with acute changes in mental status, inattention, and disorganized thinking or altered level of consciousness, a diagnosis of delirium can be made. The investigators considered patients to be delirious when CAM-ICU was positive for more than 24 h. The investigators reviewed clinical information for the study patients including age, sex, and underlying disease. Trauma factors reviewed were cause of trauma, ISS, Glasgow Coma Scale (GCS) score, shock, initial lactate level, massive transfusion within 24 h, cardiopulmonary resuscitation rescue, and time taken to the hospital after trauma. Factors related to treatment included use of restraints, mechanical ventilation, and surgery. Clinical outcomes included mortality, ICU stay, mechanical ventilation duration, and hospital stay. Statistical analysis were done using both univariate (chi-square test and t-test) and multivariate (logistic regression) procedures. Results are reported as mean ± standard deviation. Significance set at a P value of less than .05. For the multivariable logistic regression, the primary outcome variable of interest was the development of delirium after trauma that was classified as either present or absent. Variables were entered for analysis based on the strength of their univariate association with the presence/absence of delirium.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
January 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Suk-Kyung

associate professor

Asan Medical Center

Eligibility Criteria

Inclusion Criteria

  • trauma patients with Injury Severity Score (ISS) more than 15

Exclusion Criteria

  • age under 15

Outcomes

Primary Outcomes

Incidence of delirium in trauma patients

Time Frame: within the 6 months after ICU admission

risk factors of delirium in trauma patients

Time Frame: within the 6 months after ICU admission

Secondary Outcomes

  • hospital stay of delirium in trauma patients(within the 6 months after ICU admission)
  • ICU stay of delirium in trauma patients(within the 6 months after ICU admission)
  • mechanical ventilation days of delirium in trauma patients(within the 6 months after ICU admission)
  • mortality of delirium in trauma patients(within the 6 months after ICU admission)

Study Sites (1)

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