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/NCT06022445</url>
    </required_header>
    <id_info>
      <org_study_id>PKUPH-model validation</org_study_id>
      <nct_id>NCT06022445</nct_id>
    </id_info>
    <brief_title>Prospective Validation of CARPET Prognostic Model for Septic Shock After Allo-HSCT</brief_title>
    <official_title>Prospective Validation of CARPET Prognostic Model for Patients With Septic Shock After Allogeneic Hematopoietic Stem Cell Transplantation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University People's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Navy General Hospital, Beijing</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Second Hospital of Shanxi Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Second Hospital of Hebei Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shanghai Zhongshan Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shanxi Dayi Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>People's Hospital of Xinjiang Uygur Autonomous Region</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Guangzhou University of Chinese Medicine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The First Affiliated Hospital of Zhengzhou University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Peking Union Medical College</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>First Affiliated Hospital of Harbin Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Peking University People's Hospital</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>
        Validation of CARPET prognostic model for septic shock after allo-HSCT: a multicenter,&#xD;
        prospective, and cohort study&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A clinical prognostic model named CARPET model for septic shock after allo-HSCT has been&#xD;
        developed and internally retrospectively validated. A multicenter, prospective cohort study&#xD;
        is planned to validate this clinical prediction model again.&#xD;
  &#xD;
        The equation of the prediction model for 28-day mortality was as follows:&#xD;
  &#xD;
        Probability(28-day mortality)=(exp⁡(Y))/(1+exp⁡(Y)) where Y=2.343+1.328* Time of septic&#xD;
        shock- 0.085* Albumin + 0.016 * Bilirubin-0.003*PaO2/FiO2 +0.127*Lactate- 0.011 * Glomerular&#xD;
        filtration rate&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 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>28-day mortality</measure>
      <time_frame>28 days</time_frame>
      <description>Dead or alive at day 28 after septic shock diagnosis</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>ICU length of stay</measure>
      <time_frame>up to 1 year</time_frame>
      <description>Days in the ICU after septic shock diagnosis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>90-day mortality</measure>
      <time_frame>90 days</time_frame>
      <description>Dead or alive at day 90 after septic shock diagnosis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time on ventilator</measure>
      <time_frame>up to 1 year</time_frame>
      <description>Days in need of mechanical ventilation</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Stem Cell Transplant Complications</condition>
    <arm_group>
      <arm_group_label>Patients with septic shock after allo-HSCT</arm_group_label>
      <description>patients who underwent allo-HSCT and experienced septic shock</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>CARPET prognostic model</intervention_name>
      <description>For patients diagnosed with septic shock, we obtained the information in CARPET prognostic model including time of septic shock, albumin, bilirubin, PaO2/FiO2, lactate, and GFR. We calculated the CARPET risk score and the 28-day mortality probability according to CARPET logistic regression model.</description>
      <arm_group_label>Patients with septic shock after allo-HSCT</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          We included patients diagnosed with septic shock after allo-HSCT. The clinical criteria of&#xD;
          septic shock were sepsis as defined by suspected or documented infection and an acute&#xD;
          increase of ≥ 2 SOFA points, together with vasopressor therapy (norepinephrine, dopamine,&#xD;
          vasopressin, or any other vasopressor) needed to elevate mean arterial pressure ≥ 65 mmHg&#xD;
          and lactate &gt;2 mmol/L (18 mg/dL) despite adequate fluid resuscitation.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age &gt;18 years&#xD;
  &#xD;
            -  underwent allo-HSCT&#xD;
  &#xD;
            -  diagnosed with septic shock&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  experienced septic shock before enrollment&#xD;
  &#xD;
            -  relapsed or progressed after HSCT&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xiaohui Zhang, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking University Insititute of Hematology, Peking University People's Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xiaohui Zhang, MD</last_name>
      <phone>+86 13522338836</phone>
      <email>zhangxh@bjmu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Peking University Insititute of Hematology, Peking University People's Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100010</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 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>Peking University People's Hospital</investigator_affiliation>
      <investigator_full_name>Xiao Hui Zhang</investigator_full_name>
      <investigator_title>Vice president of Peking University Institute of Hematology</investigator_title>
    </responsible_party>
    <keyword>septic shock</keyword>
    <keyword>prognostic model</keyword>
    <keyword>allogeneic hematopoietic stem cell transplant</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Shock, Septic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Individual anonymised participant data will be made available to researchers upon reasonable request after termination and publication of the study.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>After the termination and publication of the study</ipd_time_frame>
      <ipd_access_criteria>Reasonable request by researcher based on study protocol.</ipd_access_criteria>
    </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/NCT06022445
  org study id: PKUPH-model validation
  nct id: NCT06022445
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Validation of CARPET prognostic model for septic shock after allo-HSCT: a multicenter,
        prospective, and cohort study
  A clinical prognostic model named CARPET model for septic shock after allo-HSCT has been
        developed and internally retrospectively validated. A multicenter, prospective cohort study
        is planned to validate this clinical prediction model again.
  
        The equation of the prediction model for 28-day mortality was as follows:
  
        Probability(28-day mortality)=(exp⁡(Y))/(1+exp⁡(Y)) where Y=2.343+1.328* Time of septic
        shock- 0.085* Albumin + 0.016 * Bilirubin-0.003*PaO2/FiO2 +0.127*Lactate- 0.011 * Glomerular
        filtration rate
  observational model: Cohort
  time perspective: Prospective
  measure: 28-day mortality
  time frame: 28 days
  description: Dead or alive at day 28 after septic shock diagnosis
  measure: ICU length of stay
  time frame: up to 1 year
  description: Days in the ICU after septic shock diagnosis
  measure: 90-day mortality
  time frame: 90 days
  description: Dead or alive at day 90 after septic shock diagnosis
  measure: Time on ventilator
  time frame: up to 1 year
  description: Days in need of mechanical ventilation
  arm group label: Patients with septic shock after allo-HSCT
  description: patients who underwent allo-HSCT and experienced septic shock
  intervention type: Other
  intervention name: CARPET prognostic model
  description: For patients diagnosed with septic shock, we obtained the information in CARPET prognostic model including time of septic shock, albumin, bilirubin, PaO2/FiO2, lactate, and GFR. We calculated the CARPET risk score and the 28-day mortality probability according to CARPET logistic regression model.
  arm group label: Patients with septic shock after allo-HSCT
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Xiaohui Zhang, MD
  role: Principal Investigator
  affiliation: Peking University Insititute of Hematology, Peking University People's Hospital
  last name: Xiaohui Zhang, MD
  phone: +86 13522338836
  email: zhangxh@bjmu.edu.cn
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Peking University People's Hospital
  investigator full name: Xiao Hui Zhang
  investigator title: Vice president of Peking University Institute of Hematology
  mesh term: Shock, Septic
  sharing ipd: Yes
  ipd description: Individual anonymised participant data will be made available to researchers upon reasonable request after termination and publication of the study.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Analytic Code
  ipd time frame: After the termination and publication of the study
  ipd access criteria: Reasonable request by researcher based on study protocol.