<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/NCT03835091</url>
  </required_header>
  <id_info>
    <org_study_id>PO18167</org_study_id>
    <nct_id>NCT03835091</nct_id>
  </id_info>
  <brief_title>Use of BRASS in Sedated Critically-ill Patients as a Predictable Mortality Factor</brief_title>
  <acronym>BRASS-ICU</acronym>
  <official_title>Use of BRASS in Sedated Critically-ill Patients as a Predictable Mortality Factor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CHU de Reims</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CHU de Reims</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>
      Sedation is used for 30 to 70 % of all intensive care unit (ICU) patients. Deep sedation can&#xD;
      be used for lot of disease like acute respiratory distress syndrome, septic shock.&#xD;
&#xD;
      Deep sedation was defined by RASS (Richmond Assessment Sedation Scale) below -3.&#xD;
&#xD;
      Deep sedation can be associated with increased mortality, length stay, duration of mechanical&#xD;
      ventilation, acute brain dysfunction.&#xD;
&#xD;
      The french exploration neurologic group in ICU developed a score used Brainstem response&#xD;
      patterns in patient deeply sedated by midazolam and showed that a high BRASS score is&#xD;
      associated with high mortality at day 28.&#xD;
&#xD;
      The investigators think that BRASS score isn't associated with the medication used for&#xD;
      sedation.&#xD;
&#xD;
      In this study the investigators included all patients sedated independently of medication&#xD;
      used for sedation, we also excluded patient with neurologic disorder.&#xD;
&#xD;
      The main objective is to shown that high BRASS score at admission of patient without&#xD;
      neurologic disorder sedated is predictive of 28-day mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sedation is used for 30 to 70 % of all intensive care unit (ICU) patients. Deep sedation can&#xD;
      be used for lot of disease like acute respiratory distress syndrome, septic shock.&#xD;
&#xD;
      Deep sedation was defined by RASS (Richmond Assessment Sedation Scale) below -3.&#xD;
&#xD;
      Deep sedation can be associated with increased mortality, length stay, duration of mechanical&#xD;
      ventilation, acute brain dysfunction.&#xD;
&#xD;
      The french exploration neurologic group in ICU developed a score used Brainstem response&#xD;
      patterns in patient deeply sedated by midazolam and showed that a high BRASS score is&#xD;
      associated with high mortality at day 28.&#xD;
&#xD;
      The investigators think that BRASS score isn't associated with the medication used for&#xD;
      sedation.&#xD;
&#xD;
      In this study the investigators included all patients sedated independently of medication&#xD;
      used for sedation, we also excluded patient with neurologic disorder.&#xD;
&#xD;
      The main objective is to shown that high BRASS score at admission of patient without&#xD;
      neurologic disorder sedated is predictive of 28-day mortality.&#xD;
&#xD;
      The BRASS score will be done in the 6 hours within admission. The Richmond Assessment&#xD;
      Sedation Scale (RASS) and Full Outline of unresponsiveness (FOUR) will be performed.&#xD;
&#xD;
      The patient characteristic's will be recorded (sex, age, Simplified Acute Physiology Score II&#xD;
      (SAPS II), medical or surgical admission, diagnosis at ICU admission (ARDS, sepsis,…), the&#xD;
      reason of initiation of mechanical ventilation, the reason of sedation (agitation, analgesia,&#xD;
      asynchrony with ventilator).&#xD;
&#xD;
      The medication for sedation and the level at time of examination, the time between admission&#xD;
      and examination will be recorded.&#xD;
&#xD;
      For the outcome, the duration of mechanical ventilation, the duration of sedation&#xD;
      administration, the occurrence of delirium evaluated by Confusion Assessment Method-&#xD;
      intensive care unit (CAM-ICU), the length stay in ICU, death at day 28 and 90 will be&#xD;
      reported.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2019</start_date>
  <completion_date type="Actual">August 26, 2019</completion_date>
  <primary_completion_date type="Actual">May 29, 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>mortality within 28 days after ICU admission</measure>
    <time_frame>28 days</time_frame>
    <description>percentage of patients who died within 28 days after admission</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mortality within 90 days after ICU admission</measure>
    <time_frame>90 days</time_frame>
    <description>percentage of patients who died within 90 days after admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU Stay</measure>
    <time_frame>6 months</time_frame>
    <description>mean of duration of ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delirium</measure>
    <time_frame>6 months</time_frame>
    <description>percentage of patients with delirium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration on mechanical ventilation</measure>
    <time_frame>6 months</time_frame>
    <description>mean of duration of mechanical ventilation</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">110</enrollment>
  <condition>Brainstem Response</condition>
  <arm_group>
    <arm_group_label>Patient with mechanical ventilation and sedation</arm_group_label>
    <description>All patient hospitalized in intensive care under sedation and mechanical ventilation without neurologic disorder</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>BRASS score</intervention_name>
    <description>Brainstem response on neurologic examination</description>
    <arm_group_label>Patient with mechanical ventilation and sedation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who will be included in this study are patients with sedation and on mechanical&#xD;
        ventilation, without neurologic disorder&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient more than 18 years Hospitalized in ICU Without neurologic disorder and/or&#xD;
        neurologic pattern Under sedation and mechanical ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with legal protection No affiliation with the French Health Care system Ongoing&#xD;
        pregnancy Inability to obtain consent Not to resuscitate decision Neurologic disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu Reims</name>
      <address>
        <city>Reims</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>March 20, 2020</last_update_submitted>
  <last_update_submitted_qc>March 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <!-- 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/NCT03835091
org study id: PO18167
nct id: NCT03835091
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sedation is used for 30 to 70 % of all intensive care unit (ICU) patients. Deep sedation can
      be used for lot of disease like acute respiratory distress syndrome, septic shock.

      Deep sedation was defined by RASS (Richmond Assessment Sedation Scale) below -3.

      Deep sedation can be associated with increased mortality, length stay, duration of mechanical
      ventilation, acute brain dysfunction.

      The french exploration neurologic group in ICU developed a score used Brainstem response
      patterns in patient deeply sedated by midazolam and showed that a high BRASS score is
      associated with high mortality at day 28.

      The investigators think that BRASS score isn't associated with the medication used for
      sedation.

      In this study the investigators included all patients sedated independently of medication
      used for sedation, we also excluded patient with neurologic disorder.

      The main objective is to shown that high BRASS score at admission of patient without
      neurologic disorder sedated is predictive of 28-day mortality.
Sedation is used for 30 to 70 % of all intensive care unit (ICU) patients. Deep sedation can
      be used for lot of disease like acute respiratory distress syndrome, septic shock.

      Deep sedation was defined by RASS (Richmond Assessment Sedation Scale) below -3.

      Deep sedation can be associated with increased mortality, length stay, duration of mechanical
      ventilation, acute brain dysfunction.

      The french exploration neurologic group in ICU developed a score used Brainstem response
      patterns in patient deeply sedated by midazolam and showed that a high BRASS score is
      associated with high mortality at day 28.

      The investigators think that BRASS score isn't associated with the medication used for
      sedation.

      In this study the investigators included all patients sedated independently of medication
      used for sedation, we also excluded patient with neurologic disorder.

      The main objective is to shown that high BRASS score at admission of patient without
      neurologic disorder sedated is predictive of 28-day mortality.

      The BRASS score will be done in the 6 hours within admission. The Richmond Assessment
      Sedation Scale (RASS) and Full Outline of unresponsiveness (FOUR) will be performed.

      The patient characteristic's will be recorded (sex, age, Simplified Acute Physiology Score II
      (SAPS II), medical or surgical admission, diagnosis at ICU admission (ARDS, sepsis,…), the
      reason of initiation of mechanical ventilation, the reason of sedation (agitation, analgesia,
      asynchrony with ventilator).

      The medication for sedation and the level at time of examination, the time between admission
      and examination will be recorded.

      For the outcome, the duration of mechanical ventilation, the duration of sedation
      administration, the occurrence of delirium evaluated by Confusion Assessment Method-
      intensive care unit (CAM-ICU), the length stay in ICU, death at day 28 and 90 will be
      reported.
observational model: Cohort
time perspective: Prospective
measure: mortality within 28 days after ICU admission
time frame: 28 days
description: percentage of patients who died within 28 days after admission
measure: mortality within 90 days after ICU admission
time frame: 90 days
description: percentage of patients who died within 90 days after admission
measure: ICU Stay
time frame: 6 months
description: mean of duration of ICU stay
measure: Delirium
time frame: 6 months
description: percentage of patients with delirium
measure: duration on mechanical ventilation
time frame: 6 months
description: mean of duration of mechanical ventilation
arm group label: Patient with mechanical ventilation and sedation
description: All patient hospitalized in intensive care under sedation and mechanical ventilation without neurologic disorder
intervention type: Other
intervention name: BRASS score
description: Brainstem response on neurologic examination
arm group label: Patient with mechanical ventilation and sedation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Critical Illness