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/NCT06006754</url>
    </required_header>
    <id_info>
      <org_study_id>Microbiome-Shock-Trial</org_study_id>
      <nct_id>NCT06006754</nct_id>
    </id_info>
    <brief_title>Influence of Enteral Microbiome on Mortality of Patients With Cardiogenic Shock</brief_title>
    <official_title>Influence of Enteral Microbiome Composition and Microbiome Dependent Metabolites on Mortality of Patients With Cardiogenic Shock</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Essen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Essen</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>
        Cardiogenic shock is associated with a high mortality. The microbiome is a double-edged sword&#xD;
        which can convey protective and detrimental cardiovascular effects. The significance of the&#xD;
        enteral micobiome on cardiovascular mortality of patients with cardiogenic shock is still not&#xD;
        known.&#xD;
  &#xD;
        This study aims to provide a deeper understanding of the role of the enteral microbiome and&#xD;
        microbiome dependent metabolites in mortality and disease progression of patients with&#xD;
        cardiogenic shock.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 30, 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</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>Correlation between enteral microbiome composition and mortality</measure>
      <time_frame>Sampling will be performed within 24 hours of onset of cardiogenic shock and clinical evaluation will be performed after 1 month</time_frame>
      <description>Stool samples are collected and clinical evaluation will be performed at below mentioned time points</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Correlation between TMAO serum level and mortality</measure>
      <time_frame>Sampling will be performed within 24 hours of onset of cardiogenic shock and on day 3</time_frame>
      <description>Blood samples are collected at below mentioned time points</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between SCFA serum level and mortality</measure>
      <time_frame>Sampling will be performed within 24 hours of onset of cardiogenic shock and on day 3</time_frame>
      <description>Blood samples are collected at below mentioned time points</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between inflammatory profile (CRP, PCT, Interleukin panel) and mortality</measure>
      <time_frame>Sampling will be performed within 24 hours of onset of cardiogenic shock and on day 3</time_frame>
      <description>Blood samples are collected at below mentioned time points</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Cardiogenic Shock</condition>
    <condition>Microbial Colonization</condition>
    <condition>Out-Of-Hospital Cardiac Arrest</condition>
    <condition>Acute Heart Failure</condition>
    <condition>Acute Myocardial Infarction</condition>
    <arm_group>
      <arm_group_label>Cardiogenic shock</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Observational study</intervention_name>
      <description>No intervention: observational study</description>
      <arm_group_label>Cardiogenic shock</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients older than 18 years presenting to the clinic with cardiogenic shock will be&#xD;
          included into the study within a 24 hours timeframe after onset&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  &gt;18y&#xD;
  &#xD;
            -  signs of cardiogenic shock regardless of etiology&#xD;
  &#xD;
                 -  lactate &gt;3mmol/L&#xD;
  &#xD;
                 -  and signs of organ dysfunction (urine output &lt;30 ml/h, cold extremities, altered&#xD;
                    mental status)&#xD;
  &#xD;
                 -  and systolic blood pressure &lt;90 mmHg for &gt;30 minutes or need for vasopressor&#xD;
                    therapy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pregnancy/lactation period&#xD;
  &#xD;
            -  antibiotic treatment within &gt;24h&#xD;
  &#xD;
            -  chronic inflammatory bowel disease&#xD;
  &#xD;
            -  short bowel syndrome&#xD;
  &#xD;
            -  artificial bowel outlet&#xD;
  &#xD;
            -  persistent diarrhea or vomiting in the past 3 months&#xD;
  &#xD;
            -  simultaneous participation in another interfering nutrition study&#xD;
  &#xD;
            -  active chemo or radiation therapy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Christos Rammos, Prof. Dr.</last_name>
      <role>Study Chair</role>
      <affiliation>University Clinic Essen</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Christos Rammos, Prof. Dr.</last_name>
      <phone>0049201723</phone>
      <phone_ext>4801</phone_ext>
      <email>christos.rammos@uk-essen.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tienush Rassaf, Prof. Dr.</last_name>
      <phone>0049201723</phone>
      <phone_ext>4801</phone_ext>
      <email>tienush.rassaf@uk-essen.de</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Hospital Essen</name>
        <address>
          <city>Essen</city>
          <state>NRW</state>
          <zip>45147</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Christos Rammos, Professor</last_name>
        <phone>+49 (0)201-723</phone>
        <phone_ext>84808</phone_ext>
        <email>christos.rammos@uk-essen.de</email>
      </contact>
    </location>
    <location_countries>
      <country>Germany</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 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Hospital, Essen</investigator_affiliation>
      <investigator_full_name>Chistos Rammos</investigator_full_name>
      <investigator_title>Professor Dr. med.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Infections</mesh_term>
      <mesh_term>Myocardial Infarction</mesh_term>
      <mesh_term>Out-of-Hospital Cardiac Arrest</mesh_term>
      <mesh_term>Shock, Cardiogenic</mesh_term>
      <mesh_term>Infarction</mesh_term>
      <mesh_term>Shock</mesh_term>
    </condition_browse>
    <!-- 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/NCT06006754
  org study id: Microbiome-Shock-Trial
  nct id: NCT06006754
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Cardiogenic shock is associated with a high mortality. The microbiome is a double-edged sword
        which can convey protective and detrimental cardiovascular effects. The significance of the
        enteral micobiome on cardiovascular mortality of patients with cardiogenic shock is still not
        known.
  
        This study aims to provide a deeper understanding of the role of the enteral microbiome and
        microbiome dependent metabolites in mortality and disease progression of patients with
        cardiogenic shock.
  observational model: Cohort
  time perspective: Prospective
  measure: Correlation between enteral microbiome composition and mortality
  time frame: Sampling will be performed within 24 hours of onset of cardiogenic shock and clinical evaluation will be performed after 1 month
  description: Stool samples are collected and clinical evaluation will be performed at below mentioned time points
  measure: Correlation between TMAO serum level and mortality
  time frame: Sampling will be performed within 24 hours of onset of cardiogenic shock and on day 3
  description: Blood samples are collected at below mentioned time points
  measure: Correlation between SCFA serum level and mortality
  time frame: Sampling will be performed within 24 hours of onset of cardiogenic shock and on day 3
  description: Blood samples are collected at below mentioned time points
  measure: Correlation between inflammatory profile (CRP, PCT, Interleukin panel) and mortality
  time frame: Sampling will be performed within 24 hours of onset of cardiogenic shock and on day 3
  description: Blood samples are collected at below mentioned time points
  arm group label: Cardiogenic shock
  intervention type: Other
  intervention name: Observational study
  description: No intervention: observational study
  arm group label: Cardiogenic shock
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Christos Rammos, Prof. Dr.
  role: Study Chair
  affiliation: University Clinic Essen
  last name: Christos Rammos, Prof. Dr.
  phone: 0049201723
  phone ext: 4801
  email: christos.rammos@uk-essen.de
  last name: Tienush Rassaf, Prof. Dr.
  phone: 0049201723
  phone ext: 4801
  email: tienush.rassaf@uk-essen.de
  facility: 
  status: Recruiting
  contact: 
  country: Germany
  responsible party type: Principal Investigator
  investigator affiliation: University Hospital, Essen
  investigator full name: Chistos Rammos
  investigator title: Professor Dr. med.
  mesh term: Communicable Diseases
  mesh term: Infections
  mesh term: Myocardial Infarction
  mesh term: Out-of-Hospital Cardiac Arrest
  mesh term: Shock, Cardiogenic
  mesh term: Infarction
  mesh term: Shock