<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/NCT01674660</url>
  </required_header>
  <id_info>
    <org_study_id>BeijingCYH</org_study_id>
    <secondary_id>19860805</secondary_id>
    <nct_id>NCT01674660</nct_id>
  </id_info>
  <brief_title>Factors Associated With Interdialytic Blood Pressure Variability in Maintenance Hemodialysis Patients</brief_title>
  <official_title>Factors Associated With Interdialytic Blood Pressure Variability in Maintenance Hemodialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Chao Yang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Chao Yang Hospital</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to explore the factors associated with interdialytic blood&#xD;
      pressure variability in maintenance hemodialysis patients, especially the association between&#xD;
      volume status and blood pressure variability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hemodialysis patients experience higher rates of cardiovascular morbidity and mortality than&#xD;
      the general population and many populations with other chronic diseases. This exceptional&#xD;
      risk is explained in part by known risk factors such as diabetes, hypertension, and other&#xD;
      uremia-related factors, including vascular calcification and stiffness, autonomic&#xD;
      dysfunction, and a high burden of circulating inflammatory mediators. However, additional&#xD;
      unidentified risk factors also likely contribute to the disproportionately high prevalence of&#xD;
      cardiovascular morbidity in hemodialysis patients. Blood pressure variability may represent&#xD;
      one plausible cardiovascular risk factor. Data from nonuremic human populations show an&#xD;
      association between greater blood pressure variability and cardiovascular events,nonfatal&#xD;
      cardiovascular events,stroke,and increased left ventricular mass. There has been&#xD;
      comparatively little work examining the causes and effects of blood pressure variability in&#xD;
      hemodialysis populations. So the purpose of this study is to explore the factors associated&#xD;
      with interdialytic blood pressure variability in maintenance hemodialysis patients,&#xD;
      especially the association between volume status and blood pressure variability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">March 2013</completion_date>
  <primary_completion_date type="Anticipated">January 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>interdialytic blood pressure</measure>
    <time_frame>44 hours</time_frame>
    <description>Ambulatory BP monitoring was performed after the midweek hemodialysis session for 44 hours. Ambulatory BPs were recorded every 20 minutes during the day (6 AM to 10 PM) and every 30 minutes during the night (10 PM to 6 AM) in the nonaccess arm, We use the coefficient of variation or standard deviation in interdialytic blood pressure as a indicator of systolic blood pressure variability.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Kidney Failure, Chronic</condition>
  <arm_group>
    <arm_group_label>volume status</arm_group_label>
    <description>volume status:group1 over volume status,group2 normal volume status,group3 low volume status</description>
  </arm_group>
  <arm_group>
    <arm_group_label>night blood pressure</arm_group_label>
    <description>night blood pressure：group1 nondipper,group2 dipper,group3 extreme dipper,group4 riser</description>
  </arm_group>
  <arm_group>
    <arm_group_label>interdialysis weight gain</arm_group_label>
    <description>interdialysis weight gain:group1 &gt;5% dry weight,group2 &lt;5% dry weight</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood, serum, white cells, urine.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        hemodialysis patients of Beijing Chaoyang Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18 years or older&#xD;
&#xD;
          -  receipt of thrice-weekly in-center hemodialysis&#xD;
&#xD;
          -  no anticipation of imminent(&lt;6 months)living related kidney transplant&#xD;
&#xD;
          -  not transfer of care to a nonparticipating facility&#xD;
&#xD;
          -  no dialytic modality change&#xD;
&#xD;
          -  free of vascular, infectious, or bleeding complication within 1 month Exclusion&#xD;
             Criteria:&#xD;
&#xD;
          -  who missed &gt;2 hemodialysis treatments over 1 month&#xD;
&#xD;
          -  abused drugs&#xD;
&#xD;
          -  severe anemia，malnutrition，chronic atrial fibrillation&#xD;
&#xD;
          -  body mass index of 40 &gt;kg/m2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ma WH weihua, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Chao Yang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cui TG Taigen, Dr.</last_name>
    <phone>010-85231510</phone>
    <email>fujine_521@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ma WH Weihua, Master</last_name>
    <phone>010-85231952</phone>
    <email>maweihua_521@sina.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nephrology, dialysis center,Beijing Chaoyang Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100020</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Ma WH Weihua, Master</last_name>
      <phone>010-85231952</phone>
      <email>maweihua_521@sina.com</email>
    </contact>
    <contact_backup>
      <last_name>Cui TG taigen, Dr.</last_name>
      <phone>010-85231952</phone>
      <email>fujine_521@sina.com</email>
    </contact_backup>
    <investigator>
      <last_name>Ma WH weihua, Master</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>August 29, 2012</last_update_submitted>
  <last_update_submitted_qc>August 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 31, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Chao Yang Hospital</investigator_affiliation>
    <investigator_full_name>Ma Weihua</investigator_full_name>
    <investigator_title>Principal Investigater</investigator_title>
  </responsible_party>
  <keyword>hemodialysis</keyword>
  <keyword>blood pressure variability</keyword>
  <keyword>volume status</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Kidney Failure, Chronic</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/NCT01674660
org study id: BeijingCYH
secondary id: 19860805
nct id: NCT01674660
lead sponsor: 
The purpose of this study is to explore the factors associated with interdialytic blood
      pressure variability in maintenance hemodialysis patients, especially the association between
      volume status and blood pressure variability.
Hemodialysis patients experience higher rates of cardiovascular morbidity and mortality than
      the general population and many populations with other chronic diseases. This exceptional
      risk is explained in part by known risk factors such as diabetes, hypertension, and other
      uremia-related factors, including vascular calcification and stiffness, autonomic
      dysfunction, and a high burden of circulating inflammatory mediators. However, additional
      unidentified risk factors also likely contribute to the disproportionately high prevalence of
      cardiovascular morbidity in hemodialysis patients. Blood pressure variability may represent
      one plausible cardiovascular risk factor. Data from nonuremic human populations show an
      association between greater blood pressure variability and cardiovascular events,nonfatal
      cardiovascular events,stroke,and increased left ventricular mass. There has been
      comparatively little work examining the causes and effects of blood pressure variability in
      hemodialysis populations. So the purpose of this study is to explore the factors associated
      with interdialytic blood pressure variability in maintenance hemodialysis patients,
      especially the association between volume status and blood pressure variability.
observational model: Case-Control
time perspective: Cross-Sectional
measure: interdialytic blood pressure
time frame: 44 hours
description: Ambulatory BP monitoring was performed after the midweek hemodialysis session for 44 hours. Ambulatory BPs were recorded every 20 minutes during the day (6 AM to 10 PM) and every 30 minutes during the night (10 PM to 6 AM) in the nonaccess arm, We use the coefficient of variation or standard deviation in interdialytic blood pressure as a indicator of systolic blood pressure variability.
arm group label: volume status
description: volume status:group1 over volume status,group2 normal volume status,group3 low volume status
arm group label: night blood pressure
description: night blood pressure：group1 nondipper,group2 dipper,group3 extreme dipper,group4 riser
arm group label: interdialysis weight gain
description: interdialysis weight gain:group1 >5% dry weight,group2 <5% dry weight
whole blood, serum, white cells, urine.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 24 Years
maximum age: 85 Years
healthy volunteers: No
last name: Ma WH weihua, Master
role: Principal Investigator
affiliation: Beijing Chao Yang Hospital
last name: Cui TG Taigen, Dr.
phone: 010-85231510
email: fujine_521@sina.com
last name: Ma WH Weihua, Master
phone: 010-85231952
email: maweihua_521@sina.com
facility: 
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Chao Yang Hospital
investigator full name: Ma Weihua
investigator title: Principal Investigater
mesh term: Renal Insufficiency
mesh term: Kidney Failure, Chronic