xml: <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/NCT06008067</url>
    </required_header>
    <id_info>
      <org_study_id>TAPSESEPTIC</org_study_id>
      <nct_id>NCT06008067</nct_id>
    </id_info>
    <brief_title>The Prognostic Role of Tricuspid Annular Plane Systolic Excursion in Critically Ill Patients With Septic Shock</brief_title>
    <official_title>The Prognostic Role of Tricuspid Annular Plane Systolic Excursion in Critically Ill Patients With Septic Shock</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alexandria University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alexandria University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to evaluate the possible prognostic performance of RV dysfunction,&#xD;
        as assessed by TAPSE, in non-cardiac patients with septic shock.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The objective is to investigate the prognostic performance of right ventricular dysfunction,&#xD;
        as assessed by tricuspid annular plane systolic excursion (TAPSE), in non-cardiac patients&#xD;
        with septic shock.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Actual">July 1, 2023</completion_date>
    <primary_completion_date type="Actual">July 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>28-day mortality</measure>
      <time_frame>Day 28</time_frame>
      <description>Mortality rate after at day 28.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">100</enrollment>
    <condition>Septic Shock</condition>
    <arm_group>
      <arm_group_label>Survivors</arm_group_label>
      <description>Patients who survived after day 28.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-survivors</arm_group_label>
      <description>Patients who died at or before day 28.</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>tricuspid annular plane systolic excursion (TAPSE)</intervention_name>
      <description>Echocardiography</description>
      <arm_group_label>Non-survivors</arm_group_label>
      <arm_group_label>Survivors</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients (18 - 64 years old) with septic shock after admission according to 2016&#xD;
          consensus definition (Sepsis-3).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients (18 - 64 years old) with septic shock after admission according to 2016&#xD;
               consensus definition (Sepsis-3).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant females&#xD;
  &#xD;
            -  Trauma&#xD;
  &#xD;
            -  Documented coronary heart disease&#xD;
  &#xD;
            -  History of myocardial infarction&#xD;
  &#xD;
            -  Myocarditis&#xD;
  &#xD;
            -  Thrombo-embolic pulmonary disease&#xD;
  &#xD;
            -  Valvular heart disease&#xD;
  &#xD;
            -  Corpulmonale&#xD;
  &#xD;
            -  Arrhythmia&#xD;
  &#xD;
            -  Known left ventricular ejection fraction &lt; 40%&#xD;
  &#xD;
            -  Poor echocardiographic window&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Tamer Habib, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Alexandria</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Faculty of Medicine, Alexandria University Hospitals</name>
        <address>
          <city>Alexandria</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Critical Care</keyword>
    <keyword>Septic Shock</keyword>
    <keyword>Echocardiography</keyword>
    <keyword>RV dysfunction</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Shock, Septic</mesh_term>
      <mesh_term>Shock</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06008067
  org study id: TAPSESEPTIC
  nct id: NCT06008067
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate the possible prognostic performance of RV dysfunction,
        as assessed by TAPSE, in non-cardiac patients with septic shock.
  The objective is to investigate the prognostic performance of right ventricular dysfunction,
        as assessed by tricuspid annular plane systolic excursion (TAPSE), in non-cardiac patients
        with septic shock.
  observational model: Cohort
  time perspective: Prospective
  measure: 28-day mortality
  time frame: Day 28
  description: Mortality rate after at day 28.
  arm group label: Survivors
  description: Patients who survived after day 28.
  arm group label: Non-survivors
  description: Patients who died at or before day 28.
  intervention type: Radiation
  intervention name: tricuspid annular plane systolic excursion (TAPSE)
  description: Echocardiography
  arm group label: Non-survivors
  arm group label: Survivors
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 64 Years
  last name: Tamer Habib, MD
  role: Principal Investigator
  affiliation: University of Alexandria
  facility: 
  country: Egypt
  responsible party type: Sponsor
  mesh term: Shock, Septic
  mesh term: Shock
  sharing ipd: No