<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/NCT03001921</url>
  </required_header>
  <id_info>
    <org_study_id>WISHES</org_study_id>
    <nct_id>NCT03001921</nct_id>
  </id_info>
  <brief_title>Wise Practice of Chinese Hemodialysis (WISHES)</brief_title>
  <official_title>Wise Practice of Chinese Hemodialysis (WISHES)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are registering all HD patients at recruited hospitals and developing a HD&#xD;
      database in China. Patients will be follow-up every 3 months, and both baseline and follow-up&#xD;
      information will be entered into the registration system. The patient survival, technical&#xD;
      survival, patency rate of access, quality of life and residual renal function for HD patients&#xD;
      will be compared using the HD database.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators are registering all end stage renal disease (ESRD) patients receiving&#xD;
      hemodialysis (HD) treatment, and developing a HD database in China. Patients' demographic&#xD;
      characteristics (including age, gender, height, weight, BMI, smoking, drinking, and&#xD;
      education), clinical characteristics (including systolic blood pressure, diastolic blood&#xD;
      pressure, primary cause of ESRD, and lab measurements of serum, urine, and access patency),&#xD;
      complications, drug information and scores of quality of life at the baseline will be&#xD;
      collected. Patients will be follow-up every 3 month, the demographic and clinical&#xD;
      characteristics, complications and drug information of patients will be collected at each&#xD;
      visit. The investigators also record the outcome at each visit, such as mortality (including&#xD;
      all-cause mortality and cardiovascular disease mortality), technical survival, kidney&#xD;
      transplantation, transfer to peritoneal dialysis, hospitalization, access failure，etc. The&#xD;
      patient survival, technical survival, patency rate of access, quality of life and residual&#xD;
      renal function for HD patients will be compared using the HD database.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Anticipated">December 2027</completion_date>
  <primary_completion_date type="Anticipated">December 2026</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Patient survival of HD patients</measure>
    <time_frame>10 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life evaluated using SF36 scale for HD patients</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patency rate of access for HD patients</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30000</enrollment>
  <condition>Haemolyses and Related Conditions</condition>
  <arm_group>
    <arm_group_label>Hemodialysis patients</arm_group_label>
    <description>End stage renal disease patients receiving hemodialysis treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>Registration of all HD patients in the First Affiliated Hospital of Sun Yat-sen University and other hospital which have signed the contract in China.</description>
    <arm_group_label>Hemodialysis patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      he serum, urine, and DNA will be collected.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        End stage renal disease patients receiving hemodialysis treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        End stage renal disease patients receiving hemodialysis treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        No&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xueqing Yu, M.D. &amp; Ph.D.</last_name>
    <email>yuxq@mail.sysu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xunhua Zheng, M.D. &amp; Ph.D.</last_name>
    <email>wilson_zxh@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The 1st Affiliated Hospital, Sun Yet-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xueqing Yu, M.D. &amp; Ph.D.</last_name>
      <email>yuxq@mail.sysu.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Xueqing Yu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>October 20, 2020</last_update_submitted>
  <last_update_submitted_qc>October 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Xue Qing Yu</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Hemodialysis</keyword>
  <keyword>Patient survival</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Hemodialysis access</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemolysis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03001921
org study id: WISHES
nct id: NCT03001921
lead sponsor: 
has dmc: Yes
The investigators are registering all HD patients at recruited hospitals and developing a HD
      database in China. Patients will be follow-up every 3 months, and both baseline and follow-up
      information will be entered into the registration system. The patient survival, technical
      survival, patency rate of access, quality of life and residual renal function for HD patients
      will be compared using the HD database.
The investigators are registering all end stage renal disease (ESRD) patients receiving
      hemodialysis (HD) treatment, and developing a HD database in China. Patients' demographic
      characteristics (including age, gender, height, weight, BMI, smoking, drinking, and
      education), clinical characteristics (including systolic blood pressure, diastolic blood
      pressure, primary cause of ESRD, and lab measurements of serum, urine, and access patency),
      complications, drug information and scores of quality of life at the baseline will be
      collected. Patients will be follow-up every 3 month, the demographic and clinical
      characteristics, complications and drug information of patients will be collected at each
      visit. The investigators also record the outcome at each visit, such as mortality (including
      all-cause mortality and cardiovascular disease mortality), technical survival, kidney
      transplantation, transfer to peritoneal dialysis, hospitalization, access failure，etc. The
      patient survival, technical survival, patency rate of access, quality of life and residual
      renal function for HD patients will be compared using the HD database.
observational model: Cohort
time perspective: Prospective
measure: Patient survival of HD patients
time frame: 10 years
measure: Quality of life evaluated using SF36 scale for HD patients
time frame: 10 years
measure: Patency rate of access for HD patients
time frame: 10 years
arm group label: Hemodialysis patients
description: End stage renal disease patients receiving hemodialysis treatment
intervention type: Other
intervention name: No intervention
description: Registration of all HD patients in the First Affiliated Hospital of Sun Yat-sen University and other hospital which have signed the contract in China.
arm group label: Hemodialysis patients
he serum, urine, and DNA will be collected.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xueqing Yu, M.D. & Ph.D.
email: yuxq@mail.sysu.edu.cn
last name: Xunhua Zheng, M.D. & Ph.D.
email: wilson_zxh@126.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Xue Qing Yu
investigator title: Professor
mesh term: Hemolysis
sharing ipd: Yes