<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/NCT03004963</url>
  </required_header>
  <id_info>
    <org_study_id>[2016]101K</org_study_id>
    <nct_id>NCT03004963</nct_id>
  </id_info>
  <brief_title>Bioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients.</brief_title>
  <official_title>Bioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RenJi Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Peritoneal dialysis (PD) is one of established treatments in the end stage renal disease&#xD;
      patients. Volume overload is a predictor of mortality in PD patients. In this Randomized&#xD;
      controlled trial, the investigators use the Body Composition Monitor (BCM), a multifrequency&#xD;
      bioimpedance device, to measure the level of overhydration in PD patients and explore its&#xD;
      value in fluid management in peritoneal dialysis patients as well as their prognosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Optimal fluid management is one of the primary objectives of dialysis treatment, and there is&#xD;
      significant concern that peritoneal dialysis (PD) patients can become progressively&#xD;
      fluid-loaded with time on treatment, especially as residual kidney function declines. Body&#xD;
      Composition Monitor (BCM) has the potential to enable better management of fluid balance. The&#xD;
      investigators undertake a prospective, randomized, open-label, controlled trial to determine&#xD;
      whether availability of longitudinal BCM measures help clinicians maintain stable fluid&#xD;
      status over 24 months in 300 peritoneal dialysis patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>volume status</measure>
    <time_frame>96 weeks</time_frame>
    <description>change in overhydration(OH) value</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The incidence of cardiovascular events</measure>
    <time_frame>96 weeks</time_frame>
    <description>different incidence of cardiovascular diseases</description>
  </primary_outcome>
  <primary_outcome>
    <measure>patient mortality</measure>
    <time_frame>96 weeks</time_frame>
    <description>different rates of all-cause patient mortality and cardiovascular mortality</description>
  </primary_outcome>
  <primary_outcome>
    <measure>technique failure</measure>
    <time_frame>96 weeks</time_frame>
    <description>different incidence of technique failure during peritoneal dialysis treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>blood pressure</measure>
    <time_frame>96 weeks</time_frame>
    <description>change in blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>residual renal function</measure>
    <time_frame>96 weeks</time_frame>
    <description>decline rate of residual renal function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>peritoneal function</measure>
    <time_frame>96 weeks</time_frame>
    <description>differences of peritoneal solute transport rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart function</measure>
    <time_frame>96 weeks</time_frame>
    <description>differences of ejection fraction (EF) in echocardiography</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>End Stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>clinical group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>evaluate the volume status just according to clinical indexes in this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>clinical and BCM group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Both body composition monitor (BCM) and clinical indexes are used to evaluate the volume status of patients in this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Body composition monitor</intervention_name>
    <description>Both body composition monitor (BCM) is used to evaluate the volume status of patients.</description>
    <arm_group_label>clinical and BCM group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>clinical indexes</intervention_name>
    <description>The investigators evaluate the volume status of patients according to clinical indexes.</description>
    <arm_group_label>clinical and BCM group</arm_group_label>
    <arm_group_label>clinical group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 18 years or older but no older than 80 years.&#xD;
&#xD;
          -  who had been on chronic peritoneal dialysis for more than 3 months.&#xD;
&#xD;
          -  All of them have signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  were expected to stop PD treatment in 6 months;&#xD;
&#xD;
          -  were amputees;&#xD;
&#xD;
          -  had a cardiac pacemaker or metallic implants;&#xD;
&#xD;
          -  had peritonitis one month before recruitment;&#xD;
&#xD;
          -  treated together with hemodialysis;&#xD;
&#xD;
          -  were during pregnancy or lactation;&#xD;
&#xD;
          -  were positive with HIV;&#xD;
&#xD;
          -  had serious diseases, including cancer, infection and liver cirrhosis, which were not&#xD;
             suitable for the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei Fang, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Nephrology, Renji Hospital, Shanghai Jiaotong University, School of Medicine, Shanghai</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wei Fang, Dr</last_name>
    <phone>13621722995</phone>
    <email>fangwei_sh@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xiaoxiao Yang, Dr</last_name>
    <phone>18817314230</phone>
    <email>yangxiaoxiao_1988@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of nephrology , Renji Hospital, Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Fang, Dr.</last_name>
      <phone>13621722995</phone>
      <email>fangwei_sh@126.com</email>
    </contact>
    <investigator>
      <last_name>Wei Fang, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>December 28, 2016</last_update_submitted>
  <last_update_submitted_qc>December 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Peritoneal Dialysis</keyword>
  <keyword>Volume Status</keyword>
  <keyword>Body Composition Monitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</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/NCT03004963
org study id: [2016]101K
nct id: NCT03004963
lead sponsor: 
has dmc: Yes
Peritoneal dialysis (PD) is one of established treatments in the end stage renal disease
      patients. Volume overload is a predictor of mortality in PD patients. In this Randomized
      controlled trial, the investigators use the Body Composition Monitor (BCM), a multifrequency
      bioimpedance device, to measure the level of overhydration in PD patients and explore its
      value in fluid management in peritoneal dialysis patients as well as their prognosis.
Optimal fluid management is one of the primary objectives of dialysis treatment, and there is
      significant concern that peritoneal dialysis (PD) patients can become progressively
      fluid-loaded with time on treatment, especially as residual kidney function declines. Body
      Composition Monitor (BCM) has the potential to enable better management of fluid balance. The
      investigators undertake a prospective, randomized, open-label, controlled trial to determine
      whether availability of longitudinal BCM measures help clinicians maintain stable fluid
      status over 24 months in 300 peritoneal dialysis patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: volume status
time frame: 96 weeks
description: change in overhydration(OH) value
measure: The incidence of cardiovascular events
time frame: 96 weeks
description: different incidence of cardiovascular diseases
measure: patient mortality
time frame: 96 weeks
description: different rates of all-cause patient mortality and cardiovascular mortality
measure: technique failure
time frame: 96 weeks
description: different incidence of technique failure during peritoneal dialysis treatment
measure: blood pressure
time frame: 96 weeks
description: change in blood pressure
measure: residual renal function
time frame: 96 weeks
description: decline rate of residual renal function
measure: peritoneal function
time frame: 96 weeks
description: differences of peritoneal solute transport rate
measure: heart function
time frame: 96 weeks
description: differences of ejection fraction (EF) in echocardiography
arm group label: clinical group
arm group type: Active Comparator
description: evaluate the volume status just according to clinical indexes in this group.
arm group label: clinical and BCM group
arm group type: Experimental
description: Both body composition monitor (BCM) and clinical indexes are used to evaluate the volume status of patients in this group.
intervention type: Device
intervention name: Body composition monitor
description: Both body composition monitor (BCM) is used to evaluate the volume status of patients.
arm group label: clinical and BCM group
intervention type: Device
intervention name: clinical indexes
description: The investigators evaluate the volume status of patients according to clinical indexes.
arm group label: clinical and BCM group
arm group label: clinical group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Wei Fang, Dr
role: Principal Investigator
affiliation: Department of Nephrology, Renji Hospital, Shanghai Jiaotong University, School of Medicine, Shanghai
last name: Wei Fang, Dr
phone: 13621722995
email: fangwei_sh@126.com
last name: Xiaoxiao Yang, Dr
phone: 18817314230
email: yangxiaoxiao_1988@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Kidney Failure, Chronic
sharing ipd: Undecided