<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/NCT03813459</url>
  </required_header>
  <id_info>
    <org_study_id>UCIP1</org_study_id>
    <nct_id>NCT03813459</nct_id>
  </id_info>
  <brief_title>Subsyndromal Delirium in Intensive Care Unit</brief_title>
  <acronym>SubSynD</acronym>
  <official_title>Subsyndromal Delirium in Intensive Care Unit, a Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro Hospitalar Lisboa Ocidental</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Orion Corporation, Orion Pharma</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Centro Hospitalar Lisboa Ocidental</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Subsyndromal delirium (SSD) is a condition characterized by a less severe cognitive&#xD;
      impairment in comparison to delirium. To date there is no published consensus on SSD&#xD;
      definitions and has been commonly reported as an intermediate stage between delirium and&#xD;
      normal mental states.&#xD;
&#xD;
      SSD encompasses some of the delirium symptoms, and has been diagnosed with Intensive Care&#xD;
      Delirium Screening Checklist scale (ICDSC) and Confusion Assessment Method-ICU (CAM-ICU).&#xD;
&#xD;
      The objective of this study is to identify subsyndromal delirium prevalence, the association&#xD;
      between SSD and clinical outcomes and understanding the relationship between SSD and&#xD;
      conversion to delirium.&#xD;
&#xD;
      The relevance of this study is understanding of subsyndromal delirium in ICU, namely the&#xD;
      importance of early presentations of acute brain dysfunction in the patients outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      SubSynD is a prospective, observational, multicenter clinical study, involving 400 patients&#xD;
      in Intensive Care Units, to assess subsyndromal delirium.&#xD;
&#xD;
      A systematic screening for delirium and subsyndromal delirium (SSD) is done with Intensive&#xD;
      Care Delirium Screening Checklist (ICDSC) and Confusion Assessment Method-ICU (CAM-ICU).&#xD;
      Scales are applied once per day until ICU discharge or for up to 14 days of being in ICU.&#xD;
&#xD;
      The investigators access three different groups of patients: non-delirium, delirium and&#xD;
      subsyndromal delirium. It is intended that either ICDSC or CAM-ICU, paired with a Richmond&#xD;
      Agitation and Sedation Scale (RASS) be administered once per day (i.e. with first assessment&#xD;
      in the morning). All patients with abnormal CAM-ICU or ICDSC features, beside the underlying&#xD;
      cause of delirium and SSD are included. In addition, data regarding baseline demographic and&#xD;
      clinical characteristics will be collected as well as data regarding the procedure performed&#xD;
      (see Case Report Form (CRF)).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</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>Number of patients with conversion from subsyndromal delirium to delirium during the period of study</measure>
    <time_frame>14 days</time_frame>
    <description>ICDSC performed 1 time per day and determine how subsyndromal delirium (ICDSC 1-3) can have conversion to delirium (ICDSC &gt;/=4).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>28 days</time_frame>
    <description>defined as number of days that patients survived in 28 days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ventilation free days</measure>
    <time_frame>28 days</time_frame>
    <description>defined has the number of days from day 1 to day 28 on which a patient breathed without assistance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>24 months</time_frame>
    <description>days until ICU discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>24 months</time_frame>
    <description>days until ICU discharge</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">400</enrollment>
  <condition>Delirium</condition>
  <arm_group>
    <arm_group_label>Subsyndromal delirium positive</arm_group_label>
    <description>Presence of Subsyndromal delirium in Intensive Care patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delirium positive</arm_group_label>
    <description>Presence of Delirium in Intensive Care patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No delirium</arm_group_label>
    <description>Non subsyndromal delirium or delirium in Intensive Care patients</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Intensive Care Unit patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years;&#xD;
&#xD;
          2. Admission in Intensive care Unit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Primary neurological diagnosis, with Glasgow Coma Scale (GCS) &lt;14 on ICU admission or&#xD;
             in previous days;&#xD;
&#xD;
          2. Blindness or deafness;&#xD;
&#xD;
          3. Aphasia;&#xD;
&#xD;
          4. Inability to communicate in the native language of the country where the study is&#xD;
             enrolled;&#xD;
&#xD;
          5. Death during the first 24 hours;&#xD;
&#xD;
          6. Limitation of therapeutic efforts in the Intensive Care Unit admission;&#xD;
&#xD;
          7. Refusal to participate;&#xD;
&#xD;
          8. Previous diagnosis of dementia or psychiatric illness;&#xD;
&#xD;
          9. Readmission in ICU;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria C Paulino, MD</last_name>
    <role>Study Director</role>
    <affiliation>Centro Hospitalar de Lisboa Ocidental</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maria Carolina Vieira Júlio Paulino</name>
      <address>
        <city>Lisboa</city>
        <zip>1300-346</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <reference>
    <citation>Boettger S, Nunez DG, Meyer R, Richter A, Schubert M, Jenewein J. Subsyndromal delirium in the intensive care setting: Phenomenological characteristics and discrimination of subsyndromal delirium versus no and full-syndromal delirium. Palliat Support Care. 2018 Feb;16(1):3-13. doi: 10.1017/S1478951517000104. Epub 2017 Mar 6.</citation>
    <PMID>28262089</PMID>
  </reference>
  <reference>
    <citation>Brummel NE, Boehm LM, Girard TD, Pandharipande PP, Jackson JC, Hughes CG, Patel MB, Han JH, Vasilevskis EE, Thompson JL, Chandrasekhar R, Bernard GR, Dittus RS, Ely EW. Subsyndromal Delirium and Institutionalization Among Patients With Critical Illness. Am J Crit Care. 2017 Nov;26(6):447-455. doi: 10.4037/ajcc2017263.</citation>
    <PMID>29092867</PMID>
  </reference>
  <reference>
    <citation>Serafim RB, Soares M, Bozza FA, Lapa E Silva JR, Dal-Pizzol F, Paulino MC, Povoa P, Salluh JIF. Outcomes of subsyndromal delirium in ICU: a systematic review and meta-analysis. Crit Care. 2017 Jul 12;21(1):179. doi: 10.1186/s13054-017-1765-3.</citation>
    <PMID>28697802</PMID>
  </reference>
  <reference>
    <citation>Yamada C, Iwawaki Y, Harada K, Fukui M, Morimoto M, Yamanaka R. Frequency and risk factors for subsyndromal delirium in an intensive care unit. Intensive Crit Care Nurs. 2018 Aug;47:15-22. doi: 10.1016/j.iccn.2018.02.010. Epub 2018 Mar 30.</citation>
    <PMID>29606481</PMID>
  </reference>
  <reference>
    <citation>Corona A, Colombo R, Catena E. Early Identification of Subsyndromal Delirium in the Critically Ill: Don't Let the Delirium Rise! Crit Care Med. 2016 Mar;44(3):644-5. doi: 10.1097/CCM.0000000000001544. No abstract available.</citation>
    <PMID>26901554</PMID>
  </reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 13, 2019</study_first_submitted>
  <study_first_submitted_qc>January 19, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>December 11, 2021</last_update_submitted>
  <last_update_submitted_qc>December 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centro Hospitalar Lisboa Ocidental</investigator_affiliation>
    <investigator_full_name>Maria Carolina Vieira Júlio Paulino</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Delirium</keyword>
  <keyword>Subsyndromal delirium</keyword>
  <keyword>Intensive Care Unit</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/NCT03813459
org study id: UCIP1
nct id: NCT03813459
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Subsyndromal delirium (SSD) is a condition characterized by a less severe cognitive
      impairment in comparison to delirium. To date there is no published consensus on SSD
      definitions and has been commonly reported as an intermediate stage between delirium and
      normal mental states.

      SSD encompasses some of the delirium symptoms, and has been diagnosed with Intensive Care
      Delirium Screening Checklist scale (ICDSC) and Confusion Assessment Method-ICU (CAM-ICU).

      The objective of this study is to identify subsyndromal delirium prevalence, the association
      between SSD and clinical outcomes and understanding the relationship between SSD and
      conversion to delirium.

      The relevance of this study is understanding of subsyndromal delirium in ICU, namely the
      importance of early presentations of acute brain dysfunction in the patients outcome.
SubSynD is a prospective, observational, multicenter clinical study, involving 400 patients
      in Intensive Care Units, to assess subsyndromal delirium.

      A systematic screening for delirium and subsyndromal delirium (SSD) is done with Intensive
      Care Delirium Screening Checklist (ICDSC) and Confusion Assessment Method-ICU (CAM-ICU).
      Scales are applied once per day until ICU discharge or for up to 14 days of being in ICU.

      The investigators access three different groups of patients: non-delirium, delirium and
      subsyndromal delirium. It is intended that either ICDSC or CAM-ICU, paired with a Richmond
      Agitation and Sedation Scale (RASS) be administered once per day (i.e. with first assessment
      in the morning). All patients with abnormal CAM-ICU or ICDSC features, beside the underlying
      cause of delirium and SSD are included. In addition, data regarding baseline demographic and
      clinical characteristics will be collected as well as data regarding the procedure performed
      (see Case Report Form (CRF)).
observational model: Cohort
time perspective: Prospective
measure: Number of patients with conversion from subsyndromal delirium to delirium during the period of study
time frame: 14 days
description: ICDSC performed 1 time per day and determine how subsyndromal delirium (ICDSC 1-3) can have conversion to delirium (ICDSC >/=4).
measure: Mortality
time frame: 28 days
description: defined as number of days that patients survived in 28 days
measure: Ventilation free days
time frame: 28 days
description: defined has the number of days from day 1 to day 28 on which a patient breathed without assistance
measure: ICU length of stay
time frame: 24 months
description: days until ICU discharge
measure: Hospital length of stay
time frame: 24 months
description: days until ICU discharge
arm group label: Subsyndromal delirium positive
description: Presence of Subsyndromal delirium in Intensive Care patients
arm group label: Delirium positive
description: Presence of Delirium in Intensive Care patients
arm group label: No delirium
description: Non subsyndromal delirium or delirium in Intensive Care patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Maria C Paulino, MD
role: Study Director
affiliation: Centro Hospitalar de Lisboa Ocidental
facility: 
country: Portugal
citation: Boettger S, Nunez DG, Meyer R, Richter A, Schubert M, Jenewein J. Subsyndromal delirium in the intensive care setting: Phenomenological characteristics and discrimination of subsyndromal delirium versus no and full-syndromal delirium. Palliat Support Care. 2018 Feb;16(1):3-13. doi: 10.1017/S1478951517000104. Epub 2017 Mar 6.
PMID: 28262089
citation: Brummel NE, Boehm LM, Girard TD, Pandharipande PP, Jackson JC, Hughes CG, Patel MB, Han JH, Vasilevskis EE, Thompson JL, Chandrasekhar R, Bernard GR, Dittus RS, Ely EW. Subsyndromal Delirium and Institutionalization Among Patients With Critical Illness. Am J Crit Care. 2017 Nov;26(6):447-455. doi: 10.4037/ajcc2017263.
PMID: 29092867
citation: Serafim RB, Soares M, Bozza FA, Lapa E Silva JR, Dal-Pizzol F, Paulino MC, Povoa P, Salluh JIF. Outcomes of subsyndromal delirium in ICU: a systematic review and meta-analysis. Crit Care. 2017 Jul 12;21(1):179. doi: 10.1186/s13054-017-1765-3.
PMID: 28697802
citation: Yamada C, Iwawaki Y, Harada K, Fukui M, Morimoto M, Yamanaka R. Frequency and risk factors for subsyndromal delirium in an intensive care unit. Intensive Crit Care Nurs. 2018 Aug;47:15-22. doi: 10.1016/j.iccn.2018.02.010. Epub 2018 Mar 30.
PMID: 29606481
citation: Corona A, Colombo R, Catena E. Early Identification of Subsyndromal Delirium in the Critically Ill: Don't Let the Delirium Rise! Crit Care Med. 2016 Mar;44(3):644-5. doi: 10.1097/CCM.0000000000001544. No abstract available.
PMID: 26901554
responsible party type: Principal Investigator
investigator affiliation: Centro Hospitalar Lisboa Ocidental
investigator full name: Maria Carolina Vieira Júlio Paulino
investigator title: Principal Investigator
mesh term: Delirium
sharing ipd: Undecided