<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/NCT03244293</url>
  </required_header>
  <id_info>
    <org_study_id>MUGraz6</org_study_id>
    <nct_id>NCT03244293</nct_id>
  </id_info>
  <brief_title>Bispectral Index (BIS) for Classification of Procalcitonin (PCT) Sepsis Grades in Critically Ill Patients With Sepsis</brief_title>
  <acronym>BIS6</acronym>
  <official_title>Sensitivity and Specificity of Bispectral Index (BIS) for Classification of Procalcitonin (PCT) Sepsis Grades in Critically Ill Patients With Sepsis, Severe Sepsis and Septic Shock and Multiple Organ Failure (MOF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Suez Canal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Suez Canal University</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>
      To evaluate the discriminative power of BIS monitoring to classify the degree of mental state&#xD;
      associated with the PCT graded sepsis cascade, and to assess its utility for monitoring the&#xD;
      improvement or deterioration of sepsis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the discriminative power of BIS monitoring to classify the degree of mental state&#xD;
      associated with the PCT graded sepsis cascade, and to assess its utility for monitoring the&#xD;
      improvement or deterioration of sepsis. The primary endpoint of our study was to use an&#xD;
      artefact-free 10-min mean BIS value to classify the degree of sepsis. As secondary endpoints,&#xD;
      we correlated the mean BIS value to various mental state and sepsis parameters; PCT,&#xD;
      C-reactive protein (CRP), Glasgow coma scale, and sequential organ failure assessment (SOFA)&#xD;
      score. In a longitudinal study, patients' PCT sepsis grades were reassessed at a later time&#xD;
      point and a second artefact-free 10-min mean BIS value was recorded to evaluate BIS evolution&#xD;
      within the same patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Anticipated">January 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Bispectral Index (BIS)-Electroencephalography (EEG) derived parameter correlated to the severity of Sepsis as indicated by Procalcitonin (PCT) biomarker.</measure>
    <time_frame>Time point 1= On CCU admission, Time point 2= day 3 of CCU admission, Time point 3= on release from CCU.</time_frame>
    <description>Bispectral Index (BIS)-Electroencephalography (EEG) derived parameter (scale from 0=brain dead to 100= normal EEG) will be monitored and correlated to the severity of Sepsis as indicated by daily measured Procalcitonin (PCT) biomarker (&lt;0.5 micg/L =no sepsis up to 100 micg/L =Septic shock)</description>
  </primary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Sepsis, Severe</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Critical Care patients with all grades of Sepsis monitored with bispectral index&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: patients with sepsis&#xD;
&#xD;
          -  patients with sepsis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who received drugs that would interfere with BIS monitoring&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ashraf Dahaba, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Suez Canal University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ashraf Dahaba</last_name>
    <phone>00436509006761</phone>
    <email>ashraf.dahaba@medunigraz.at</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dalian Medical University</name>
      <address>
        <city>Dalian</city>
        <state>Dalian</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhaoyang Xiao, MD</last_name>
    </contact>
    <investigator>
      <last_name>Ashraf Dahaba, MD, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <removed_countries>
    <country>Austria</country>
  </removed_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>May 4, 2022</last_update_submitted>
  <last_update_submitted_qc>May 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Suez Canal University</investigator_affiliation>
    <investigator_full_name>Ashraf A. Dahaba</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Toxemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03244293
org study id: MUGraz6
nct id: NCT03244293
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the discriminative power of BIS monitoring to classify the degree of mental state
      associated with the PCT graded sepsis cascade, and to assess its utility for monitoring the
      improvement or deterioration of sepsis.
To evaluate the discriminative power of BIS monitoring to classify the degree of mental state
      associated with the PCT graded sepsis cascade, and to assess its utility for monitoring the
      improvement or deterioration of sepsis. The primary endpoint of our study was to use an
      artefact-free 10-min mean BIS value to classify the degree of sepsis. As secondary endpoints,
      we correlated the mean BIS value to various mental state and sepsis parameters; PCT,
      C-reactive protein (CRP), Glasgow coma scale, and sequential organ failure assessment (SOFA)
      score. In a longitudinal study, patients' PCT sepsis grades were reassessed at a later time
      point and a second artefact-free 10-min mean BIS value was recorded to evaluate BIS evolution
      within the same patient.
observational model: Case-Only
time perspective: Prospective
measure: Bispectral Index (BIS)-Electroencephalography (EEG) derived parameter correlated to the severity of Sepsis as indicated by Procalcitonin (PCT) biomarker.
time frame: Time point 1= On CCU admission, Time point 2= day 3 of CCU admission, Time point 3= on release from CCU.
description: Bispectral Index (BIS)-Electroencephalography (EEG) derived parameter (scale from 0=brain dead to 100= normal EEG) will be monitored and correlated to the severity of Sepsis as indicated by daily measured Procalcitonin (PCT) biomarker (<0.5 micg/L =no sepsis up to 100 micg/L =Septic shock)
intervention type: Other
intervention name: no intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ashraf Dahaba, MD, MSc
role: Principal Investigator
affiliation: Suez Canal University
last name: Ashraf Dahaba
phone: 00436509006761
email: ashraf.dahaba@medunigraz.at
facility: 
status: Recruiting
contact: 
investigator: 
country: China
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Suez Canal University
investigator full name: Ashraf A. Dahaba
investigator title: Principle Investigator
mesh term: Sepsis
mesh term: Toxemia
sharing ipd: No