<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/NCT04405830</url>
  </required_header>
  <id_info>
    <org_study_id>RRT-Jsph</org_study_id>
    <nct_id>NCT04405830</nct_id>
  </id_info>
  <brief_title>Outcome of Patients Treated With RRT</brief_title>
  <official_title>Outcome of Patients Treated With Renal Replacement Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>No</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>
      Acute Kidney Injury (AKI) is a common serious complication after cardiac surgery. AKI not&#xD;
      only prolongs the hospitalization time of patients undergoing cardiac surgery and increases&#xD;
      the cost of treatment, but also is an independent risk factor for postoperative death. The&#xD;
      aim of this study is to investigate the outcome of patients treated with renal replacement&#xD;
      therapy (RRT), and to evaluate the short-term and long-term outcomes of patients with RRT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2012</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2025</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>30 days after Renal replacement therapy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU Length of Stay (LOS)</measure>
    <time_frame>from ICU admission to ICU discharge, within 30 days of admission</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Acute Kidney Injury</condition>
  <condition>Cardiac Surgery</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Renal replacement therapy</intervention_name>
    <description>Renal replacement therapy (RRT) refers to modalities of treatment that are used to replace the waste filtering functions of a normal kidney.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients receiving RRT for renal support&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Critically ill patients undergoing cardiovascular surgery admitted to intensive care&#xD;
             units.&#xD;
&#xD;
          -  Patients receiving RRT for renal support&#xD;
&#xD;
          -  Patients over 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients &lt;18 years&#xD;
&#xD;
          -  Refusal of consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yong-feng Shao, MD</last_name>
    <role>Study Director</role>
    <affiliation>First Hospital Affiliated to Nanjing Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hong Liu, MD</last_name>
    <phone>18801281613</phone>
    <email>DR.HONGLIU@FOXMAIL.COM</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yong-feng Shao, MD</last_name>
    <phone>02568303100</phone>
    <email>yfshaojph@sina.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The first affiliated hospital of nanjing medical university</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hong Liu, MD</last_name>
      <phone>188012181613</phone>
      <email>dr.hongliu@foxmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>April 15, 2022</last_update_submitted>
  <last_update_submitted_qc>April 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Hong Liu</investigator_full_name>
    <investigator_title>: Investigator of Department of Cardiac Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04405830
org study id: RRT-Jsph
nct id: NCT04405830
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Acute Kidney Injury (AKI) is a common serious complication after cardiac surgery. AKI not
      only prolongs the hospitalization time of patients undergoing cardiac surgery and increases
      the cost of treatment, but also is an independent risk factor for postoperative death. The
      aim of this study is to investigate the outcome of patients treated with renal replacement
      therapy (RRT), and to evaluate the short-term and long-term outcomes of patients with RRT.
observational model: Cohort
time perspective: Prospective
measure: All-cause mortality
time frame: 30 days after Renal replacement therapy
measure: ICU Length of Stay (LOS)
time frame: from ICU admission to ICU discharge, within 30 days of admission
intervention type: Procedure
intervention name: Renal replacement therapy
description: Renal replacement therapy (RRT) refers to modalities of treatment that are used to replace the waste filtering functions of a normal kidney.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Yong-feng Shao, MD
role: Study Director
affiliation: First Hospital Affiliated to Nanjing Medical University
last name: Hong Liu, MD
phone: 18801281613
email: DR.HONGLIU@FOXMAIL.COM
last name: Yong-feng Shao, MD
phone: 02568303100
email: yfshaojph@sina.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Nanjing Medical University
investigator full name: Hong Liu
investigator title: : Investigator of Department of Cardiac Surgery
mesh term: Acute Kidney Injury
sharing ipd: Undecided