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/NCT06001294</url>
    </required_header>
    <id_info>
      <org_study_id>Huaian1H</org_study_id>
      <nct_id>NCT06001294</nct_id>
    </id_info>
    <brief_title>We Collected Blood Samples From Septic Shock Patients and Measured ELABELA, Creatinine, and NGAL Levels. Survival After 7 Days Was Recorded and Analyzed to Evaluate the Potential of Serum ELABELA as an Early Diagnostic Marker for Sepsis-associated Acute Kidney Injury.</brief_title>
    <acronym>ELABELA（ELA）</acronym>
    <official_title>The Value of Serum ELABELA in Early Diagnosis of Sepsis-Associated Acute Kidney Injury</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xiangcheng Zhang</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Huai'an No.1 People's Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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 investigators selected patients diagnosed with sepsis who were admitted to the Intensive&#xD;
        Care Unit (ICU) of Huai'an First People's Hospital between June 2022 and December 2023, as&#xD;
        well as healthy individuals with normal kidney function during the same period, for the&#xD;
        research. The investigators collected blood samples from patients with septic shock or sepsis&#xD;
        at 6 hours, 12 hours, 24 hours, 48 hours, 3 days, 5 days, and 7 days after diagnosis， and&#xD;
        also collected blood samples from the healthy individuals. The blood samples were stored in&#xD;
        gel separation vacuum tubes containing heparin as an anticoagulant. The supernatant was&#xD;
        removed and stored at -80°C, and the levels of plasma ELA (enzyme-linked immunosorbent assay)&#xD;
        were measured using a standardized ELA kit. Additionally, serum NGAL (neutrophil&#xD;
        gelatinase-associated lipocalin) and creatinine levels were measured simultaneously. The&#xD;
        subjects were divided into three groups based on the KDIGO diagnostic criteria:&#xD;
        sepsis-associated acute kidney injury (S-AKI) group, sepsis non-AKI group, and normal control&#xD;
        group. Finally, the data were analyzed to determine the early diagnostic value of ELA for&#xD;
        S-AKI. Approximately 70 specimens were collected in total.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 3, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The value of ELABELA</measure>
      <time_frame>Venous blood samples were collected at 6 hours, 12 hours, 24 hours, 48 hours, 3 days, 5 days and 7 days after the diagnosis of sepsis or septic shock</time_frame>
      <description>Significance of serum ELABELA in the early diagnosis of sepsis-associated renal injury.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>7-day survival rate</measure>
      <time_frame>7-day</time_frame>
      <description>The significance of serum ELABELA in evaluating the short-term prognosis of sepsis-associated renal injury.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Sepsis</condition>
    <condition>Septic Shock</condition>
    <condition>Acute Kidney Injury</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with sepsis admitted to the ICU.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients with sepsis admitted to the ICU.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Under 18 years old;&#xD;
  &#xD;
            2. History of chronic kidney disease;&#xD;
  &#xD;
            3. Recipients of organ transplantation within the past year;&#xD;
  &#xD;
            4. Patients or their families could not give informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xiangcheng Zhang</last_name>
      <role>Study Director</role>
      <affiliation>Huai'an No.1 People's Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xiangcheng Zhang</last_name>
      <phone>+8615896169171</phone>
      <email>zhxc0318@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tiantian Wang</last_name>
      <phone>+8618829715580</phone>
      <email>wtttxjy@stu.njmu.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department of Critical Care Medicine, The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University</name>
        <address>
          <city>Huaian</city>
          <state>Jiangsu</state>
          <zip>223001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiangcheng Zhang</last_name>
        <phone>+8615896169171</phone>
        <email>zhxc0318@163.com</email>
      </contact>
      <contact_backup>
        <last_name>Tiantian Wang</last_name>
        <phone>+8618829715580</phone>
        <email>wtttxjy@stu.njmu.edu.cn</email>
      </contact_backup>
      <investigator>
        <last_name>Xiangcheng Zhang</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.</citation>
      <PMID>26903338</PMID>
    </reference>
    <reference>
      <citation>Section 2: AKI Definition. Kidney Int Suppl (2011). 2012 Mar;2(1):19-36. doi: 10.1038/kisup.2011.32. No abstract available.</citation>
      <PMID>25018918</PMID>
    </reference>
    <reference>
      <citation>Ronco C, Bellomo R, Kellum JA. Acute kidney injury. Lancet. 2019 Nov 23;394(10212):1949-1964. doi: 10.1016/S0140-6736(19)32563-2.</citation>
      <PMID>31777389</PMID>
    </reference>
    <reference>
      <citation>Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.</citation>
      <PMID>26162677</PMID>
    </reference>
    <reference>
      <citation>Bagshaw SM, Lapinsky S, Dial S, Arabi Y, Dodek P, Wood G, Ellis P, Guzman J, Marshall J, Parrillo JE, Skrobik Y, Kumar A; Cooperative Antimicrobial Therapy of Septic Shock (CATSS) Database Research Group. Acute kidney injury in septic shock: clinical outcomes and impact of duration of hypotension prior to initiation of antimicrobial therapy. Intensive Care Med. 2009 May;35(5):871-81. doi: 10.1007/s00134-008-1367-2. Epub 2008 Dec 9.</citation>
      <PMID>19066848</PMID>
    </reference>
    <reference>
      <citation>Bagshaw SM, Uchino S, Bellomo R, Morimatsu H, Morgera S, Schetz M, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Oudemans-van Straaten HM, Ronco C, Kellum JA; Beginning and Ending Supportive Therapy for the Kidney (BEST Kidney) Investigators. Septic acute kidney injury in critically ill patients: clinical characteristics and outcomes. Clin J Am Soc Nephrol. 2007 May;2(3):431-9. doi: 10.2215/CJN.03681106. Epub 2007 Mar 21.</citation>
      <PMID>17699448</PMID>
    </reference>
    <reference>
      <citation>Wen Y, Parikh CR. Current concepts and advances in biomarkers of acute kidney injury. Crit Rev Clin Lab Sci. 2021 Aug;58(5):354-368. doi: 10.1080/10408363.2021.1879000. Epub 2021 Feb 8.</citation>
      <PMID>33556265</PMID>
    </reference>
    <reference>
      <citation>Chng SC, Ho L, Tian J, Reversade B. ELABELA: a hormone essential for heart development signals via the apelin receptor. Dev Cell. 2013 Dec 23;27(6):672-80. doi: 10.1016/j.devcel.2013.11.002. Epub 2013 Dec 5.</citation>
      <PMID>24316148</PMID>
    </reference>
    <reference>
      <citation>Chen H, Wang L, Wang W, Cheng C, Zhang Y, Zhou Y, Wang C, Miao X, Wang J, Wang C, Li J, Zheng L, Huang K. ELABELA and an ELABELA Fragment Protect against AKI. J Am Soc Nephrol. 2017 Sep;28(9):2694-2707. doi: 10.1681/ASN.2016111210. Epub 2017 Jun 5.</citation>
      <PMID>28583915</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 19, 2023</last_update_submitted>
    <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Huai'an No.1 People's Hospital</investigator_affiliation>
      <investigator_full_name>Xiangcheng Zhang</investigator_full_name>
      <investigator_title>Director of Intensive Care Medicine Department, Huai'an First People's Hospital</investigator_title>
    </responsible_party>
    <keyword>sepsis associated acute kidney injury</keyword>
    <keyword>ELABELA</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sepsis</mesh_term>
      <mesh_term>Toxemia</mesh_term>
      <mesh_term>Shock, Septic</mesh_term>
      <mesh_term>Acute Kidney Injury</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06001294
  org study id: Huaian1H
  nct id: NCT06001294
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The investigators selected patients diagnosed with sepsis who were admitted to the Intensive
        Care Unit (ICU) of Huai'an First People's Hospital between June 2022 and December 2023, as
        well as healthy individuals with normal kidney function during the same period, for the
        research. The investigators collected blood samples from patients with septic shock or sepsis
        at 6 hours, 12 hours, 24 hours, 48 hours, 3 days, 5 days, and 7 days after diagnosis， and
        also collected blood samples from the healthy individuals. The blood samples were stored in
        gel separation vacuum tubes containing heparin as an anticoagulant. The supernatant was
        removed and stored at -80°C, and the levels of plasma ELA (enzyme-linked immunosorbent assay)
        were measured using a standardized ELA kit. Additionally, serum NGAL (neutrophil
        gelatinase-associated lipocalin) and creatinine levels were measured simultaneously. The
        subjects were divided into three groups based on the KDIGO diagnostic criteria:
        sepsis-associated acute kidney injury (S-AKI) group, sepsis non-AKI group, and normal control
        group. Finally, the data were analyzed to determine the early diagnostic value of ELA for
        S-AKI. Approximately 70 specimens were collected in total.
  observational model: Case-Only
  time perspective: Prospective
  measure: The value of ELABELA
  time frame: Venous blood samples were collected at 6 hours, 12 hours, 24 hours, 48 hours, 3 days, 5 days and 7 days after the diagnosis of sepsis or septic shock
  description: Significance of serum ELABELA in the early diagnosis of sepsis-associated renal injury.
  measure: 7-day survival rate
  time frame: 7-day
  description: The significance of serum ELABELA in evaluating the short-term prognosis of sepsis-associated renal injury.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Xiangcheng Zhang
  role: Study Director
  affiliation: Huai'an No.1 People's Hospital
  last name: Xiangcheng Zhang
  phone: +8615896169171
  email: zhxc0318@163.com
  last name: Tiantian Wang
  phone: +8618829715580
  email: wtttxjy@stu.njmu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: China
  citation: Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
  PMID: 26903338
  citation: Section 2: AKI Definition. Kidney Int Suppl (2011). 2012 Mar;2(1):19-36. doi: 10.1038/kisup.2011.32. No abstract available.
  PMID: 25018918
  citation: Ronco C, Bellomo R, Kellum JA. Acute kidney injury. Lancet. 2019 Nov 23;394(10212):1949-1964. doi: 10.1016/S0140-6736(19)32563-2.
  PMID: 31777389
  citation: Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.
  PMID: 26162677
  citation: Bagshaw SM, Lapinsky S, Dial S, Arabi Y, Dodek P, Wood G, Ellis P, Guzman J, Marshall J, Parrillo JE, Skrobik Y, Kumar A; Cooperative Antimicrobial Therapy of Septic Shock (CATSS) Database Research Group. Acute kidney injury in septic shock: clinical outcomes and impact of duration of hypotension prior to initiation of antimicrobial therapy. Intensive Care Med. 2009 May;35(5):871-81. doi: 10.1007/s00134-008-1367-2. Epub 2008 Dec 9.
  PMID: 19066848
  citation: Bagshaw SM, Uchino S, Bellomo R, Morimatsu H, Morgera S, Schetz M, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Oudemans-van Straaten HM, Ronco C, Kellum JA; Beginning and Ending Supportive Therapy for the Kidney (BEST Kidney) Investigators. Septic acute kidney injury in critically ill patients: clinical characteristics and outcomes. Clin J Am Soc Nephrol. 2007 May;2(3):431-9. doi: 10.2215/CJN.03681106. Epub 2007 Mar 21.
  PMID: 17699448
  citation: Wen Y, Parikh CR. Current concepts and advances in biomarkers of acute kidney injury. Crit Rev Clin Lab Sci. 2021 Aug;58(5):354-368. doi: 10.1080/10408363.2021.1879000. Epub 2021 Feb 8.
  PMID: 33556265
  citation: Chng SC, Ho L, Tian J, Reversade B. ELABELA: a hormone essential for heart development signals via the apelin receptor. Dev Cell. 2013 Dec 23;27(6):672-80. doi: 10.1016/j.devcel.2013.11.002. Epub 2013 Dec 5.
  PMID: 24316148
  citation: Chen H, Wang L, Wang W, Cheng C, Zhang Y, Zhou Y, Wang C, Miao X, Wang J, Wang C, Li J, Zheng L, Huang K. ELABELA and an ELABELA Fragment Protect against AKI. J Am Soc Nephrol. 2017 Sep;28(9):2694-2707. doi: 10.1681/ASN.2016111210. Epub 2017 Jun 5.
  PMID: 28583915
  responsible party type: Sponsor-Investigator
  investigator affiliation: Huai'an No.1 People's Hospital
  investigator full name: Xiangcheng Zhang
  investigator title: Director of Intensive Care Medicine Department, Huai'an First People's Hospital
  mesh term: Sepsis
  mesh term: Toxemia
  mesh term: Shock, Septic
  mesh term: Acute Kidney Injury
  mesh term: Wounds and Injuries
  sharing ipd: Undecided