<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/NCT03276273</url>
  </required_header>
  <id_info>
    <org_study_id>MUGraz7</org_study_id>
    <nct_id>NCT03276273</nct_id>
  </id_info>
  <brief_title>Bispectral-Electroencephalography (EEG) in First Time Hemodialysis</brief_title>
  <acronym>BIS7</acronym>
  <official_title>The Utility of Using the Bispectral Index (BIS) for Detecting Dialysis Disequilibrium Syndrome (DDS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Suez Canal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dalian Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      The severity of minimal dialysis disequilibrium syndrome (DDS) is currently detected and&#xD;
      graded clinically using clinical criteria. Bispectral Index (BIS), an electroencephalographic&#xD;
      (EEG) derived parameter is widely used in anesthesia and Critical Care setting to detect&#xD;
      effects of anesthetic/hypnotic drugs. The aim of our study was to assess the discriminative&#xD;
      power of BIS monitoring to accurately detect DDS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design: A consecutive, clinical, validation study. Setting: Medical University of Graz (Graz,&#xD;
      Austria). Patients: Twenty consecutive patients undergoing first hemodialysis are enrolled at&#xD;
      Medical University of Graz, Haemodialysis Unit. Agitated patients or patients who fell asleep&#xD;
      during the recording are excluded from the final analysis.&#xD;
&#xD;
      During the first dialysis session of approximately 3 h, patients were observed for signs of&#xD;
      disequilibrium; headaches, dizziness, nausea, vomiting, if they become obtunded, have visual&#xD;
      impairments or cramps. Accordingly patients were divided into 2 groups; the &quot;DDS group&quot; of&#xD;
      patients who experienced one of the DDS symptoms of headaches, dizziness, nausea, vomiting,&#xD;
      become obtunded, have visual impairments or cramps and patients who do not experience any of&#xD;
      the DDS symptoms in the &quot;non-DDS group&quot; An assigned nephrologist will assess the physical and&#xD;
      mental status of the patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</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>Change in the Bispectral Index value</measure>
    <time_frame>Over a period of one year Time point 1= First Hemodialysis, Time point 2= Second Hemodialysis, Time point 3= Third Hemodialysis.</time_frame>
    <description>Interpatient Change in the value of recorded Bispectral Index between patients undergoing first time hemodialysis (differences between patients) and intrapatient (differences in bispectral Index values between the first 3 hemodialysis sections of each recruited patient)</description>
  </primary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Renal Failure Acute Chronic</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>recording of Bispectral Index</intervention_name>
    <description>recording of Bispectral Index</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        First Time renal Dialysis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First Time renal Dialysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects' consumption of sedatives/hypnotics psychotropic drugs, or concomitant&#xD;
             neurological disorders affecting mental state such as hepatic encephalopathy, stroke,&#xD;
             stupor or dementia and renal transplant patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Ashraf Dahaba, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guest Professor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ashraf Dahaba, MD</last_name>
    <phone>00436509006761</phone>
    <email>ashraf.dahaba@medunigraz.at</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dalian Medical University</name>
      <address>
        <city>Dalian</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ashraf Dahaba</last_name>
      <phone>+436509006761</phone>
      <phone_ext>+436509006761</phone_ext>
    </contact>
    <contact_backup>
      <last_name>Zhaoyang Xiao</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Theodor Bilharz Research Institute</name>
      <address>
        <city>Cairo</city>
        <zip>8046</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ashraf M Dahaba, MD</last_name>
      <phone>+436509006761</phone>
      <phone_ext>+436509006761</phone_ext>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
    <country>Egypt</country>
  </location_countries>
  <removed_countries>
    <country>Austria</country>
  </removed_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>September 2, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>October 26, 2022</last_update_submitted>
  <last_update_submitted_qc>October 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 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>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Acute Kidney Injury</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/NCT03276273
org study id: MUGraz7
nct id: NCT03276273
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The severity of minimal dialysis disequilibrium syndrome (DDS) is currently detected and
      graded clinically using clinical criteria. Bispectral Index (BIS), an electroencephalographic
      (EEG) derived parameter is widely used in anesthesia and Critical Care setting to detect
      effects of anesthetic/hypnotic drugs. The aim of our study was to assess the discriminative
      power of BIS monitoring to accurately detect DDS.
Design: A consecutive, clinical, validation study. Setting: Medical University of Graz (Graz,
      Austria). Patients: Twenty consecutive patients undergoing first hemodialysis are enrolled at
      Medical University of Graz, Haemodialysis Unit. Agitated patients or patients who fell asleep
      during the recording are excluded from the final analysis.

      During the first dialysis session of approximately 3 h, patients were observed for signs of
      disequilibrium; headaches, dizziness, nausea, vomiting, if they become obtunded, have visual
      impairments or cramps. Accordingly patients were divided into 2 groups; the "DDS group" of
      patients who experienced one of the DDS symptoms of headaches, dizziness, nausea, vomiting,
      become obtunded, have visual impairments or cramps and patients who do not experience any of
      the DDS symptoms in the "non-DDS group" An assigned nephrologist will assess the physical and
      mental status of the patients.
observational model: Cohort
time perspective: Prospective
measure: Change in the Bispectral Index value
time frame: Over a period of one year Time point 1= First Hemodialysis, Time point 2= Second Hemodialysis, Time point 3= Third Hemodialysis.
description: Interpatient Change in the value of recorded Bispectral Index between patients undergoing first time hemodialysis (differences between patients) and intrapatient (differences in bispectral Index values between the first 3 hemodialysis sections of each recruited patient)
intervention type: Device
intervention name: recording of Bispectral Index
description: recording of Bispectral Index
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
last name: Ashraf Dahaba, MD
role: Principal Investigator
affiliation: Guest Professor
last name: Ashraf Dahaba, MD
phone: 00436509006761
email: ashraf.dahaba@medunigraz.at
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
country: China
country: Egypt
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Suez Canal University
investigator full name: Ashraf A. Dahaba
investigator title: Principal Investigator
mesh term: Renal Insufficiency
mesh term: Acute Kidney Injury
sharing ipd: No