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/NCT06027476</url>
    </required_header>
    <id_info>
      <org_study_id>TJH-20230608B</org_study_id>
      <nct_id>NCT06027476</nct_id>
    </id_info>
    <brief_title>Preoperative Inflammatory Status and Postoperative Acute Kidney Injury</brief_title>
    <official_title>Prognostic Significance of Preoperative Inflammatory Status for Postoperative Acute Kidney Injury in Elderly Patients Undergoing Non-cardiac Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rao Sun</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tongji 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>
        Acute kidney injury (AKI) is a common complication during the early postoperative period&#xD;
        after noncardiac surgery. Patients with AKI are at an increased risk of developing chronic&#xD;
        kidney disease, prolonging hospitalization, and experiencing higher rates of morbidity and&#xD;
        mortality. Identifying preoperative risk factors for postoperative AKI can significantly&#xD;
        contribute to the development of preventive strategies and improved perioperative care in&#xD;
        this vulnerable patient population.&#xD;
  &#xD;
        The goal of this retrospective study is to investigate the predictive value of preoperative&#xD;
        inflammatory status, as measured by complete blood count-derived inflammatory markers, such&#xD;
        as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR),&#xD;
        monocyte-to-lymphocyte ratio (MLR), derived neutrophil-to-lymphocyte ratio (dNLR),&#xD;
        neutrophil-to-lymphocyte*platelet ratio (NLPR), systemic immune-inflammatory index (SII),&#xD;
        systemic inflammatory response index (SIRI), and aggregate index of systemic inflammation&#xD;
        (AISI), on postoperative AKI in elderly patients undergoing non-cardiac surgery.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">October 5, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Postoperative acute kidney injury</measure>
      <time_frame>Within 7 days after surgery</time_frame>
      <description>In accordance with the KDIGO creatinine criteria: a serum creatinine increases of 26.5 mmol/L within 48 hours or 1.5 times baseline within 7 days after surgery.</description>
    </primary_outcome>
    <enrollment type="Anticipated">9000</enrollment>
    <condition>Postoperative Acute Kidney Injury</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Elderly patients (aged ≥ 65 years) who underwent a non-cardiac surgery at Tongji Hospital&#xD;
          between July 2018 and December 2021 were included in our study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. aged ≥ 65 years.&#xD;
  &#xD;
            2. general, gynaecological, neurosurgery, orthopaedic, or thoracic surgery.&#xD;
  &#xD;
            3. surgery duration lasting longer than one hour.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. patients with an American Society of Anesthesiologists (ASA) physical status V.&#xD;
  &#xD;
            2. those with concurrent cardiac, vascular, transplant or urological surgeries.&#xD;
  &#xD;
            3. those with end-stage renal disease (i.e. a glomerular filtration rate of 15&#xD;
               mL/min/1.73 m2 or receiving haemodialysis) or a history of kidney transplantation..&#xD;
  &#xD;
            4. those did not have sufficient data required for calculation for inflammatory markers&#xD;
               or AKI evaluation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Rao Sun</name>
        <address>
          <city>Wuhan</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 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 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Tongji Hospital</investigator_affiliation>
      <investigator_full_name>Rao Sun</investigator_full_name>
      <investigator_title>Associate chief physician</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acute Kidney Injury</mesh_term>
      <mesh_term>Wounds and Injuries</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/NCT06027476
  org study id: TJH-20230608B
  nct id: NCT06027476
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Acute kidney injury (AKI) is a common complication during the early postoperative period
        after noncardiac surgery. Patients with AKI are at an increased risk of developing chronic
        kidney disease, prolonging hospitalization, and experiencing higher rates of morbidity and
        mortality. Identifying preoperative risk factors for postoperative AKI can significantly
        contribute to the development of preventive strategies and improved perioperative care in
        this vulnerable patient population.
  
        The goal of this retrospective study is to investigate the predictive value of preoperative
        inflammatory status, as measured by complete blood count-derived inflammatory markers, such
        as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR),
        monocyte-to-lymphocyte ratio (MLR), derived neutrophil-to-lymphocyte ratio (dNLR),
        neutrophil-to-lymphocyte*platelet ratio (NLPR), systemic immune-inflammatory index (SII),
        systemic inflammatory response index (SIRI), and aggregate index of systemic inflammation
        (AISI), on postoperative AKI in elderly patients undergoing non-cardiac surgery.
  observational model: Cohort
  time perspective: Retrospective
  measure: Postoperative acute kidney injury
  time frame: Within 7 days after surgery
  description: In accordance with the KDIGO creatinine criteria: a serum creatinine increases of 26.5 mmol/L within 48 hours or 1.5 times baseline within 7 days after surgery.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: 100 Years
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Tongji Hospital
  investigator full name: Rao Sun
  investigator title: Associate chief physician
  mesh term: Acute Kidney Injury
  mesh term: Wounds and Injuries
  sharing ipd: No