Incidence and Risk Factors for Delirium in Severely Injured Patients

Completed

• Conditions: Delirium; Trauma; Intensive Care Unit Syndrome

• Registration Number: NCT03023839
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2015-07
• Status Verified: 2017-01
• Study Completion: 2017-01
• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-15
• Last Update Submitted: 2017-01-17
• Study First Posted: 2017-01-18
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

Inclusion Criteria

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

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Exclusion Criteria

• age under 15

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of delirium in trauma patients	within the 6 months after ICU admission
risk factors of delirium in trauma patients	within the 6 months after ICU admission

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of