<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/NCT02967263</url>
  </required_header>
  <id_info>
    <org_study_id>AKI-2016-01</org_study_id>
    <nct_id>NCT02967263</nct_id>
  </id_info>
  <brief_title>Etiology, Epidemiology and Prognostics of AKI</brief_title>
  <official_title>The Study of Etiology, Epidemiology and Prognostic Factors of Acute Kidney Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  To investigate the etiology and epidemiology of acute kidney injury (AKI).&#xD;
&#xD;
        -  To find out risk factors associated with the occurence of AKI.&#xD;
&#xD;
        -  To find out risk factors related to the prognosis of AKI,focusing on uremic toxins,&#xD;
           inflammation, oxidative stress and nutritional status.&#xD;
&#xD;
        -  To study on the relationship between gene polymorphism and prognosis of acute kidney&#xD;
           injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. To investigate the relationship between preexisting protein-energy wasting (PEW) and&#xD;
           adverse outcomes in patients with AKI.&#xD;
&#xD;
        2. To evaluate the association of serum nutritional variables and prognosis of AKI.&#xD;
&#xD;
        3. Given the different half-lives of serum nutritional markers, we hypothesized that the&#xD;
           utility of serum nutritional variables as prognostic predictors may differ in early&#xD;
           death (&lt;7 days) and late death (&gt;7 days, &lt;28 days) patients.&#xD;
&#xD;
        4. To investigate the various kinds of uremic toxins in AKI, furthermore, to evaluate the&#xD;
           relationship between uremic toxins, especially protein bound toxins, and short- or&#xD;
           long-term mortality in AKI patients.&#xD;
&#xD;
        5. To investigate the mineral bone disorders in AKI,and to evaluate whether these markers&#xD;
           would role as prognostic predictors of AKI.&#xD;
&#xD;
        6. Several risk factors of mortality in AKI,such as markers of PEW, inflammation and serum&#xD;
           creatinine,have been used; however, no single indicator is considered to be a &quot;gold&#xD;
           standard.&quot;&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">March 2022</completion_date>
  <primary_completion_date type="Actual">March 2022</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>all-cause mortality</measure>
    <time_frame>90 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>renal function survival rate</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>days in hospital</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">713</enrollment>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>Hospital-acquired AKI</arm_group_label>
    <description>Adult patients with Hospital-acquired AKI</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood or urine samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        adult patients aged &gt;18 years, with hospital-acquired acute kidney injury, from a&#xD;
        university-affiliated hospital in Shanghai, China.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;=18 years and &lt;= 88 years&#xD;
&#xD;
          -  clinically diagnosed with acute kidney injury, according KDIGO criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  preexisting chronic kidney failure (defined as an eGFR &lt;60 ml/min per 1.73 m2)&#xD;
&#xD;
          -  post-renal obstruction or rapid progressive glomerulonephritis as the main cause of&#xD;
             AKI&#xD;
&#xD;
          -  known acute renal dysfunction&#xD;
&#xD;
          -  hospital stays &lt;24 hours&#xD;
&#xD;
          -  malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Feng Ding, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Division of Nephrology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Ninth People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 17, 2022</last_update_submitted>
  <last_update_submitted_qc>November 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</investigator_affiliation>
    <investigator_full_name>Ding Feng</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>Acute Kidney Injury</keyword>
  <keyword>Proteinosis</keyword>
  <keyword>Epidemiology</keyword>
  <keyword>Risk factors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02967263
org study id: AKI-2016-01
nct id: NCT02967263
lead sponsor: 
has dmc: Yes
-  To investigate the etiology and epidemiology of acute kidney injury (AKI).

        -  To find out risk factors associated with the occurence of AKI.

        -  To find out risk factors related to the prognosis of AKI,focusing on uremic toxins,
           inflammation, oxidative stress and nutritional status.

        -  To study on the relationship between gene polymorphism and prognosis of acute kidney
           injury.
1. To investigate the relationship between preexisting protein-energy wasting (PEW) and
           adverse outcomes in patients with AKI.

        2. To evaluate the association of serum nutritional variables and prognosis of AKI.

        3. Given the different half-lives of serum nutritional markers, we hypothesized that the
           utility of serum nutritional variables as prognostic predictors may differ in early
           death (<7 days) and late death (>7 days, <28 days) patients.

        4. To investigate the various kinds of uremic toxins in AKI, furthermore, to evaluate the
           relationship between uremic toxins, especially protein bound toxins, and short- or
           long-term mortality in AKI patients.

        5. To investigate the mineral bone disorders in AKI,and to evaluate whether these markers
           would role as prognostic predictors of AKI.

        6. Several risk factors of mortality in AKI,such as markers of PEW, inflammation and serum
           creatinine,have been used; however, no single indicator is considered to be a "gold
           standard."
observational model: Cohort
time perspective: Prospective
measure: all-cause mortality
time frame: 90 days
measure: renal function survival rate
time frame: 90 days
measure: days in hospital
time frame: 90 days
arm group label: Hospital-acquired AKI
description: Adult patients with Hospital-acquired AKI
blood or urine samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Feng Ding, PhD
role: Study Director
affiliation: Division of Nephrology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
investigator full name: Ding Feng
investigator title: professor
mesh term: Acute Kidney Injury