<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03023839</url>
  </required_header>
  <id_info>
    <org_study_id>2014-0344</org_study_id>
    <nct_id>NCT03023839</nct_id>
  </id_info>
  <brief_title>Incidence and Risk Factors for Delirium in Severely Injured Patients</brief_title>
  <official_title>Incidence and Risk Factors for Delirium in Severely Injured Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Delirium is very common in intensive care unit (ICU) patients and leads to poor outcomes.&#xD;
      There is little information on delirium in injured patients however. This study determined&#xD;
      the incidence and risk factors for delirium in severely injured patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was a prospective cohort study that reviewed the medical records of 179 trauma&#xD;
      patients who were admitted to Asan Medical Center from January 01, 2013 to December 31, 2014.&#xD;
      The investigators included all patients who had an Injury Severity Score (ISS) of more than&#xD;
      15 and excluded patients younger than 15 years old. This study was approved by the Asan&#xD;
      Medical Center Institutional Review Board (2014-0344).&#xD;
&#xD;
      Patient delirium was checked using the Confusion Assessment Method in Intensive Care Unit&#xD;
      (CAM-ICU) three times every day. The CAM-ICU includes four features that assess acute changes&#xD;
      in or the fluctuating course of mental status, inattention, altered level of consciousness,&#xD;
      and disorganized thinking. If a patient has a Richmond Agitation Sedation Scale (RASS) score&#xD;
      of -3 or more with acute changes in mental status, inattention, and disorganized thinking or&#xD;
      altered level of consciousness, a diagnosis of delirium can be made. The investigators&#xD;
      considered patients to be delirious when CAM-ICU was positive for more than 24 h.&#xD;
&#xD;
      The investigators reviewed clinical information for the study patients including age, sex,&#xD;
      and underlying disease. Trauma factors reviewed were cause of trauma, ISS, Glasgow Coma Scale&#xD;
      (GCS) score, shock, initial lactate level, massive transfusion within 24 h, cardiopulmonary&#xD;
      resuscitation rescue, and time taken to the hospital after trauma. Factors related to&#xD;
      treatment included use of restraints, mechanical ventilation, and surgery. Clinical outcomes&#xD;
      included mortality, ICU stay, mechanical ventilation duration, and hospital stay.&#xD;
&#xD;
      Statistical analysis were done using both univariate (chi-square test and t-test) and&#xD;
      multivariate (logistic regression) procedures. Results are reported as mean ± standard&#xD;
      deviation. Significance set at a P value of less than .05. For the multivariable logistic&#xD;
      regression, the primary outcome variable of interest was the development of delirium after&#xD;
      trauma that was classified as either present or absent. Variables were entered for analysis&#xD;
      based on the strength of their univariate association with the presence/absence of delirium.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of delirium in trauma patients</measure>
    <time_frame>within the 6 months after ICU admission</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>risk factors of delirium in trauma patients</measure>
    <time_frame>within the 6 months after ICU admission</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>hospital stay of delirium in trauma patients</measure>
    <time_frame>within the 6 months after ICU admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU stay of delirium in trauma patients</measure>
    <time_frame>within the 6 months after ICU admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mechanical ventilation days of delirium in trauma patients</measure>
    <time_frame>within the 6 months after ICU admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality of delirium in trauma patients</measure>
    <time_frame>within the 6 months after ICU admission</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">179</enrollment>
  <condition>Delirium</condition>
  <condition>Trauma</condition>
  <condition>Intensive Care Unit Syndrome</condition>
  <arm_group>
    <arm_group_label>Severe trauma patients</arm_group_label>
    <description>Severe Trauma patients (ISS &gt;15) admitted to Intensive Care Unit (ICU)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Severe Trauma patients admiited to Intensive Care Unit (ICU) of Asan Medical Center from 01&#xD;
        Jan 2013 to 31 Dec 2014&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  trauma patients with Injury Severity Score (ISS) more than 15&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age under 15&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suk-kyung Hong, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ulsan College of Medicine. Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Reade MC, Finfer S. Sedation and delirium in the intensive care unit. N Engl J Med. 2014 Jan 30;370(5):444-54. doi: 10.1056/NEJMra1208705. No abstract available.</citation>
    <PMID>24476433</PMID>
  </reference>
  <reference>
    <citation>Angles EM, Robinson TN, Biffl WL, Johnson J, Moss M, Tran ZV, Moore EE. Risk factors for delirium after major trauma. Am J Surg. 2008 Dec;196(6):864-9; discussion 869-70. doi: 10.1016/j.amjsurg.2008.07.037.</citation>
    <PMID>19095101</PMID>
  </reference>
  <reference>
    <citation>Thomason JW, Shintani A, Peterson JF, Pun BT, Jackson JC, Ely EW. Intensive care unit delirium is an independent predictor of longer hospital stay: a prospective analysis of 261 non-ventilated patients. Crit Care. 2005 Aug;9(4):R375-81. doi: 10.1186/cc3729. Epub 2005 Jun 1.</citation>
    <PMID>16137350</PMID>
  </reference>
  <reference>
    <citation>Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.</citation>
    <PMID>15082703</PMID>
  </reference>
  <reference>
    <citation>Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.</citation>
    <PMID>24088092</PMID>
  </reference>
  <reference>
    <citation>Pandharipande P, Cotton BA, Shintani A, Thompson J, Pun BT, Morris JA Jr, Dittus R, Ely EW. Prevalence and risk factors for development of delirium in surgical and trauma intensive care unit patients. J Trauma. 2008 Jul;65(1):34-41. doi: 10.1097/TA.0b013e31814b2c4d.</citation>
    <PMID>18580517</PMID>
  </reference>
  <reference>
    <citation>Ansaloni L, Catena F, Chattat R, Fortuna D, Franceschi C, Mascitti P, Melotti RM. Risk factors and incidence of postoperative delirium in elderly patients after elective and emergency surgery. Br J Surg. 2010 Feb;97(2):273-80. doi: 10.1002/bjs.6843.</citation>
    <PMID>20069607</PMID>
  </reference>
  <reference>
    <citation>Gani H, Domi R, Kodra N, Prifti P, Naco M, Beqiri V, Torba D, Tare R. The incidence of postoperative delirium in elderly patients after urologic surgery. Med Arch. 2013;67(1):45-7. doi: 10.5455/medarh.2013.67.45-47.</citation>
    <PMID>23678839</PMID>
  </reference>
  <reference>
    <citation>Cavallazzi R, Saad M, Marik PE. Delirium in the ICU: an overview. Ann Intensive Care. 2012 Dec 27;2(1):49. doi: 10.1186/2110-5820-2-49.</citation>
    <PMID>23270646</PMID>
  </reference>
  <reference>
    <citation>Mistraletti G, Carloni E, Cigada M, Zambrelli E, Taverna M, Sabbatini G, Umbrello M, Elia G, Destrebecq AL, Iapichino G. Sleep and delirium in the intensive care unit. Minerva Anestesiol. 2008 Jun;74(6):329-33.</citation>
    <PMID>18500209</PMID>
  </reference>
  <reference>
    <citation>Brummel NE, Girard TD. Preventing delirium in the intensive care unit. Crit Care Clin. 2013 Jan;29(1):51-65. doi: 10.1016/j.ccc.2012.10.007.</citation>
    <PMID>23182527</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>January 17, 2017</last_update_submitted>
  <last_update_submitted_qc>January 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Suk-Kyung</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <keyword>Delirium</keyword>
  <keyword>Trauma</keyword>
  <keyword>Injury</keyword>
  <keyword>restraints</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03023839
org study id: 2014-0344
nct id: NCT03023839
lead sponsor: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Incidence of delirium in trauma patients
time frame: within the 6 months after ICU admission
measure: risk factors of delirium in trauma patients
time frame: within the 6 months after ICU admission
measure: hospital stay of delirium in trauma patients
time frame: within the 6 months after ICU admission
measure: ICU stay of delirium in trauma patients
time frame: within the 6 months after ICU admission
measure: mechanical ventilation days of delirium in trauma patients
time frame: within the 6 months after ICU admission
measure: mortality of delirium in trauma patients
time frame: within the 6 months after ICU admission
arm group label: Severe trauma patients
description: Severe Trauma patients (ISS >15) admitted to Intensive Care Unit (ICU)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Suk-kyung Hong, Ph.D
role: Principal Investigator
affiliation: University of Ulsan College of Medicine. Asan Medical Center
facility: 
country: Korea, Republic of
citation: Reade MC, Finfer S. Sedation and delirium in the intensive care unit. N Engl J Med. 2014 Jan 30;370(5):444-54. doi: 10.1056/NEJMra1208705. No abstract available.
PMID: 24476433
citation: Angles EM, Robinson TN, Biffl WL, Johnson J, Moss M, Tran ZV, Moore EE. Risk factors for delirium after major trauma. Am J Surg. 2008 Dec;196(6):864-9; discussion 869-70. doi: 10.1016/j.amjsurg.2008.07.037.
PMID: 19095101
citation: Thomason JW, Shintani A, Peterson JF, Pun BT, Jackson JC, Ely EW. Intensive care unit delirium is an independent predictor of longer hospital stay: a prospective analysis of 261 non-ventilated patients. Crit Care. 2005 Aug;9(4):R375-81. doi: 10.1186/cc3729. Epub 2005 Jun 1.
PMID: 16137350
citation: Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
PMID: 15082703
citation: Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.
PMID: 24088092
citation: Pandharipande P, Cotton BA, Shintani A, Thompson J, Pun BT, Morris JA Jr, Dittus R, Ely EW. Prevalence and risk factors for development of delirium in surgical and trauma intensive care unit patients. J Trauma. 2008 Jul;65(1):34-41. doi: 10.1097/TA.0b013e31814b2c4d.
PMID: 18580517
citation: Ansaloni L, Catena F, Chattat R, Fortuna D, Franceschi C, Mascitti P, Melotti RM. Risk factors and incidence of postoperative delirium in elderly patients after elective and emergency surgery. Br J Surg. 2010 Feb;97(2):273-80. doi: 10.1002/bjs.6843.
PMID: 20069607
citation: Gani H, Domi R, Kodra N, Prifti P, Naco M, Beqiri V, Torba D, Tare R. The incidence of postoperative delirium in elderly patients after urologic surgery. Med Arch. 2013;67(1):45-7. doi: 10.5455/medarh.2013.67.45-47.
PMID: 23678839
citation: Cavallazzi R, Saad M, Marik PE. Delirium in the ICU: an overview. Ann Intensive Care. 2012 Dec 27;2(1):49. doi: 10.1186/2110-5820-2-49.
PMID: 23270646
citation: Mistraletti G, Carloni E, Cigada M, Zambrelli E, Taverna M, Sabbatini G, Umbrello M, Elia G, Destrebecq AL, Iapichino G. Sleep and delirium in the intensive care unit. Minerva Anestesiol. 2008 Jun;74(6):329-33.
PMID: 18500209
citation: Brummel NE, Girard TD. Preventing delirium in the intensive care unit. Crit Care Clin. 2013 Jan;29(1):51-65. doi: 10.1016/j.ccc.2012.10.007.
PMID: 23182527
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Suk-Kyung
investigator title: associate professor
mesh term: Delirium
sharing ipd: Undecided