Clinical trial NCT03023839: Incidence and Risk Factors for Delirium in Severely Injured Patients
Official title: Incidence and Risk Factors for Delirium in Severely Injured Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Trauma
Intensive Care Unit Syndrome
Keywords: Delirium
Trauma
Injury
restraints
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 179
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe Trauma patients admiited to Intensive Care Unit (ICU) of Asan Medical Center from 01 Jan 2013 to 31 Dec 2014

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* age under 15

Primary outcomes:
measure: Incidence of delirium in trauma patients
timeFrame: within the 6 months after ICU admission
measure: risk factors of delirium in trauma patients
timeFrame: within the 6 months after ICU admission
Secondary outcomes:
measure: hospital stay of delirium in trauma patients
timeFrame: within the 6 months after ICU admission
measure: ICU stay of delirium in trauma patients
timeFrame: within the 6 months after ICU admission
measure: mechanical ventilation days of delirium in trauma patients
timeFrame: within the 6 months after ICU admission
measure: mortality of delirium in trauma patients
timeFrame: within the 6 months after ICU admission
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: University of Ulsan College of Medicine. Asan Medical Center
name: Suk-kyung Hong, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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