<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/NCT04408768</url>
  </required_header>
  <id_info>
    <org_study_id>El Zaiton Specialized Hospital</org_study_id>
    <nct_id>NCT04408768</nct_id>
  </id_info>
  <brief_title>Stress Hyperglycemia and Acute Ischemic Stroke</brief_title>
  <official_title>Stress Hyperglycemia as a Prognostic Factor in Acute Ischemic Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams 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>
      Whereas diabetes mellitus is clearly a risk factor for the occurrence of stroke and for its&#xD;
      poor prognosis, hyperglycemia per se is also linked to increased morbidity and mortality in&#xD;
      stroke patients.Therefore, the objective of this work was to study the glycemic status of&#xD;
      acute ischemic stroke patients and to assess its impact on stroke outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using PASS program, setting alpha error at 5% and power of 80%, the total sample size was&#xD;
      estimated to be 80 cases.&#xD;
&#xD;
      The NIHSS was used as a primary outcome; 40 cases were needed in each group. Secondary&#xD;
      outcomes were hemorrhagic transformation, hospital stay duration, mechanical ventilation,&#xD;
      need for vasopressors, and 30-days mortality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 17, 2018</start_date>
  <completion_date type="Actual">August 20, 2019</completion_date>
  <primary_completion_date type="Actual">July 9, 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>National Institutes of Health Stroke Scale (NIHSS)</measure>
    <time_frame>30 days</time_frame>
    <description>The NIHSS score categorized into: no stroke symptoms (0), mild stroke (1-4), moderate stroke (5-15), moderate to severe stroke (16-20), and sever (21-42)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>30-days mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Hemorrhagic transformation, the length of hospital stay, need for mechanical ventilation and vasopressors and 30-days mortality</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Stress Hyperglycemia</condition>
  <arm_group>
    <arm_group_label>Normal RBS</arm_group_label>
    <description>Normal RBS on ICU admission and controlled blood sugar within 24 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High RBS</arm_group_label>
    <description>High RBS on ICU admission and uncontrolled blood sugar during first 24 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard protocol for stroke patients</intervention_name>
    <description>Standard protocol for stroke patients</description>
    <arm_group_label>High RBS</arm_group_label>
    <arm_group_label>Normal RBS</arm_group_label>
    <other_name>no specific intervention</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study included eighty acute ischemic stroke patients who presented within 24 hours of&#xD;
        onset of symptoms. They were equally divided into two groups; group A included patients&#xD;
        with normal (70-150 mg/dl) RBS on ICU admission and controlled blood sugar within 24 h,&#xD;
        while group B included those with high RBS on ICU admission and uncontrolled blood sugar&#xD;
        during first 24 h.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute ischemic stroke within 24 hours of onset of symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subdural hematoma&#xD;
&#xD;
          -  Transient ischemic attack&#xD;
&#xD;
          -  Subarachnoid hemorrhage&#xD;
&#xD;
          -  Hemorrhagic stroke&#xD;
&#xD;
          -  Major comorbidities Hyperglycemia on admission that was controlled (random blood sugar&#xD;
             (RBS) &lt; 150 mg/dl) within 24 hours with insulin therapy, diabetic&#xD;
&#xD;
          -  Ketoacidosis&#xD;
&#xD;
          -  RBS less than 70 mg/dl on admission&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hanaa El Gendy</name>
      <address>
        <city>Cairo</city>
        <state>Ain Shams University Specialized Hospital</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Hanaa Mohamed Abdallah ElGendy MD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Hyperglycemia</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/NCT04408768
org study id: El Zaiton Specialized Hospital
nct id: NCT04408768
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Whereas diabetes mellitus is clearly a risk factor for the occurrence of stroke and for its
      poor prognosis, hyperglycemia per se is also linked to increased morbidity and mortality in
      stroke patients.Therefore, the objective of this work was to study the glycemic status of
      acute ischemic stroke patients and to assess its impact on stroke outcome.
Using PASS program, setting alpha error at 5% and power of 80%, the total sample size was
      estimated to be 80 cases.

      The NIHSS was used as a primary outcome; 40 cases were needed in each group. Secondary
      outcomes were hemorrhagic transformation, hospital stay duration, mechanical ventilation,
      need for vasopressors, and 30-days mortality.
observational model: Cohort
time perspective: Prospective
measure: National Institutes of Health Stroke Scale (NIHSS)
time frame: 30 days
description: The NIHSS score categorized into: no stroke symptoms (0), mild stroke (1-4), moderate stroke (5-15), moderate to severe stroke (16-20), and sever (21-42)
measure: 30-days mortality
time frame: 30 days
description: Hemorrhagic transformation, the length of hospital stay, need for mechanical ventilation and vasopressors and 30-days mortality
arm group label: Normal RBS
description: Normal RBS on ICU admission and controlled blood sugar within 24 hours
arm group label: High RBS
description: High RBS on ICU admission and uncontrolled blood sugar during first 24 hours
intervention type: Other
intervention name: standard protocol for stroke patients
description: Standard protocol for stroke patients
arm group label: High RBS
arm group label: Normal RBS
other name: no specific intervention
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Hanaa Mohamed Abdallah ElGendy MD
investigator title: Assistant Professor
mesh term: Ischemic Stroke
mesh term: Hyperglycemia
sharing ipd: Undecided