<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/NCT03754361</url>
  </required_header>
  <id_info>
    <org_study_id>URG-APD</org_study_id>
    <nct_id>NCT03754361</nct_id>
  </id_info>
  <brief_title>The Study of Efficacy and Safety of Automated PD in Urgent Start Dialysis</brief_title>
  <acronym>URG-APD</acronym>
  <official_title>The Study of Efficacy and Safety of Automated Peritoneal Dialysis in Urgent Start Dialysis as Compared With Intermittent Hemodialysis in ESRD Patients,a Multi-center, Non-blind and Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>First Hospital of China Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Anzhen Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Luhe Teaching Hospital of the Capital Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ningbo No.2 Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking Union Medical College Hospital</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>
      This is a multi-center, controlled clinical trial study. The purpose of this study is to&#xD;
      examine the efficacy and safety of automated peritoneal dialysis as compared with&#xD;
      intermittent haemodialysis for ESRD patients with indications for urgent start dialysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hemodialysis（HD） and peritoneal dialysis (PD) are both the main methods to treat with&#xD;
      end-stage renal disease (ESRD) uremia patients. The first 3-month mortality and&#xD;
      hospitalization rate of new dialysis patient is much higher than that of regular dialysis's.&#xD;
      So it is very important to set up dialysis pathway and from inducing dialysis into regular&#xD;
      dialysis smoothly. But in the global 50-70%, more than 70% of the patients in China can not&#xD;
      establish the dialysis pathway in advance according to the plan. With the common, a temporary&#xD;
      deep venous catheter would be used first, then the fistula established later, as the final&#xD;
      transition for hemodialysis. Urgent peritoneal dialysis can be established 24 hours after the&#xD;
      establishment of permanent access dialysis, simply and easily, it can protect the residual&#xD;
      kidney function; reduce treatment costs, hemodynamic stability, no anticoagulant is its&#xD;
      unique advantages, At the same time, also avoid the temporary deep venous pathway prone to&#xD;
      local bleeding, infection, venous thrombosis, central venous stenosis, direct impact on the&#xD;
      future of the mature of fistula , or transplanted kidney vascular conditions. Automatic&#xD;
      peritoneal dialysis (APD) in the treatment of urgent dialysis patients can save more manpower&#xD;
      and resources, and improve the efficiency of peritoneal dialysis. The study on the efficacy&#xD;
      and safety of urgent dialysis lacks the precisely designed multi-center, prospective and&#xD;
      controlled clinical trial, and APD only induces 3 days, it is difficult to really reflect the&#xD;
      safety and effectiveness of APD. Therefore, it is of great practical significance to study&#xD;
      the difference of safety, efficacy and cost-effectiveness between urgent PD and HD in a&#xD;
      prospective, control and multicenter clinical trial. 206 ESRD uremia patients will involve in&#xD;
      this multi-center, prospective and controlled clinical trial, the mode of urgent dialysis&#xD;
      will choose by patient guided by nephrologist, the HD group will receive the standard&#xD;
      traditional treatment: from induction HD to regular HD. The PD group will receive the APD&#xD;
      daily. All patient will be monitor the physiological and biochemical marker for 14 day, and&#xD;
      all adverse events and dead within 90days will collected to evaluated the safety, efficacy of&#xD;
      the two urgent dialysis modes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">February 28, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>the mode of urgent dialysis will choose by patient guided by nephrologist, the HD group will receive the standard traditional treatment: from induction HD to regular HD. The PD group will receive the APD daily.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>infective morbidity</measure>
    <time_frame>At 14 days after the initiation of dialysis</time_frame>
    <description>peritonitis (APD), Bacteremia and catheter-related infections (APD and IHD)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mechanical complications morbidity</measure>
    <time_frame>At 14 and 90 days after the initiation of dialysis</time_frame>
    <description>catheter leakage and migration (APD), catheter obstruction (IHD)， Exit site bleeding, pneumothorax, hernia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>dialysis related mortality</measure>
    <time_frame>At 14 and 90 days after the initiation of dialysis</time_frame>
    <description>catheter-related:Sepsis, severe thromboembolic events (massive cerebral infarction, pulmonary embolism), arrhythmia (ventricular tachycardia, ventricular fibrillation),bleeding, Congestive heart failure and ischemic heart disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>infective morbidity</measure>
    <time_frame>At 90 days after the initiation of dialysis</time_frame>
    <description>peritonitis (APD), Bacteremia and catheter-related infections (APD and IHD)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">206</enrollment>
  <condition>ESRD</condition>
  <arm_group>
    <arm_group_label>APD group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive PD catheter placement and subsequent automated peritoneal dialysis treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IHD group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive un-tunneled hemodialysis catheter placement and subsequent hemodialysis treatment 3-4 times per week,2-4 hours each time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>automated peritoneal dialysis</intervention_name>
    <description>peritoneal dialysis administered by a cycler</description>
    <arm_group_label>APD group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>IHD</intervention_name>
    <description>HD 4hour 2-3times per week</description>
    <arm_group_label>IHD group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CKD(chronic kidney disease)-5 stage patient whose eGFR（CKD-EPI（chronic kidney&#xD;
             disease-epidemiology collaboration））&lt;15 ml/min/1.73m2,occured uremic symptoms or&#xD;
             volume overload need of renal replacement therapy(RRT) within 14 days .&#xD;
&#xD;
          -  Prolonged RRT access is not available.&#xD;
&#xD;
          -  No dialysis treatment was given within 1 months.&#xD;
&#xD;
          -  The vital signs are stable and tolerable in peritoneal dialysis catheterization or&#xD;
             central venous catheterization.&#xD;
&#xD;
          -  Able to understand the whole process of the trial, voluntarily participate in and sign&#xD;
             informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Maintenance RRT alraedy.&#xD;
&#xD;
          -  Serious metabolic disorders ( hyperkalemia and acidosis) cause significant changes in&#xD;
             electrocardiogram or other emergency indications to RRT within 24 hours.&#xD;
&#xD;
          -  Hypertensive emergencies(diastolic blood pressure&gt;130mmHg)&#xD;
&#xD;
          -  Severe respiratory, circulatory or hepatic failure requires instrumental support or&#xD;
             vasoactive drugs to maintain vital signs.&#xD;
&#xD;
          -  High catabolic state eg. severe inflammation or trauma&#xD;
&#xD;
          -  Absolute contraindication of peritoneal dialysis such as recent abdominal surgery&#xD;
             (&lt;1month), multiple abdominal surgeries.&#xD;
&#xD;
          -  Absolute contraindication for hemodialysis such as hemodynamic instability (systolic&#xD;
             blood pressure &lt;80mmHg).&#xD;
&#xD;
          -  Pregnant.&#xD;
&#xD;
          -  Expected to survive for less than 1 years.&#xD;
&#xD;
          -  Plan for kidney transplantation within 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Limeng Chen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Nephrology, Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Haiyun Wang, MD</last_name>
    <phone>+86-13671063539</phone>
    <email>wanghaiyun62926@126.COM</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Peng Xia, MD</last_name>
    <phone>+86-13811684903</phone>
    <email>7-xp@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Anzhen Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guoqin Wang, MD, PhD</last_name>
      <phone>+86-13911282575</phone>
      <email>wangguoqin1@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Yumeng Zhang, BN</last_name>
      <phone>+86-13911992835</phone>
      <email>791751665@qq.com</email>
    </contact_backup>
    <investigator>
      <last_name>Hong Cheng, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Guoqin Wang, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Zhirui Zhao, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yu Wang, BN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yumeng Zhang, BN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Haiyun Wang, MD</last_name>
      <phone>+86-13671063539</phone>
      <email>wanghaiyun62926@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Peng Xia, MD</last_name>
      <phone>+86-13811684903</phone>
      <email>7-xp@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Limeng Chen, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xuemei Li, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Peng Xia, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ying Wang, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Haiyun Wang, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bingyan Liu, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Zijuan Zhou, BN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beijing Luhe Hospital Affiliated to Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>101149</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhongxin Li, master</last_name>
      <phone>13621211613</phone>
      <email>13621211613@139.com</email>
    </contact>
    <contact_backup>
      <last_name>Chunxia Shi, master</last_name>
      <phone>18701377094</phone>
      <email>422601904@qq.com</email>
    </contact_backup>
    <investigator>
      <last_name>Zhongxin Li, master</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chunxia Shi, master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yanan Shi, bachelor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Conghui Liu, master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Qianying Cao, master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li Yao, MD, PhD</last_name>
      <phone>+86-13904035673</phone>
      <email>liyao_cmu@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Xinwang Zhu, MD, PhD</last_name>
      <phone>+86-13804056472</phone>
      <email>zhuxinwang_cmu@126.com</email>
    </contact_backup>
    <investigator>
      <last_name>Li Yao, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xinwang Zhu, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Da Sun, MD, MM</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wei Wu, BN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xiaoming Zhao, BN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yanan Sun, BN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ningbo No.2 Hospital</name>
      <address>
        <city>Ningbo</city>
        <state>Zhejiang</state>
        <zip>315000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kaiyue Wang, master</last_name>
      <phone>18867861568</phone>
      <email>nbwky1716@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Kedan Cai, bachelor</last_name>
      <phone>15857415082</phone>
      <email>caikedan_1983@126.com</email>
    </contact_backup>
    <investigator>
      <last_name>Qun Luo, master</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Junfu Xu, bachelor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fangfang Zhou, master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>October 7, 2019</last_update_submitted>
  <last_update_submitted_qc>October 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>urgent start dialysis</keyword>
  <keyword>automated PD</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>To comply with laws in China, local regulations and hospital policy, IPD sharing might be restricted</ipd_description>
  </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/NCT03754361
org study id: URG-APD
nct id: NCT03754361
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a multi-center, controlled clinical trial study. The purpose of this study is to
      examine the efficacy and safety of automated peritoneal dialysis as compared with
      intermittent haemodialysis for ESRD patients with indications for urgent start dialysis.
Hemodialysis（HD） and peritoneal dialysis (PD) are both the main methods to treat with
      end-stage renal disease (ESRD) uremia patients. The first 3-month mortality and
      hospitalization rate of new dialysis patient is much higher than that of regular dialysis's.
      So it is very important to set up dialysis pathway and from inducing dialysis into regular
      dialysis smoothly. But in the global 50-70%, more than 70% of the patients in China can not
      establish the dialysis pathway in advance according to the plan. With the common, a temporary
      deep venous catheter would be used first, then the fistula established later, as the final
      transition for hemodialysis. Urgent peritoneal dialysis can be established 24 hours after the
      establishment of permanent access dialysis, simply and easily, it can protect the residual
      kidney function; reduce treatment costs, hemodynamic stability, no anticoagulant is its
      unique advantages, At the same time, also avoid the temporary deep venous pathway prone to
      local bleeding, infection, venous thrombosis, central venous stenosis, direct impact on the
      future of the mature of fistula , or transplanted kidney vascular conditions. Automatic
      peritoneal dialysis (APD) in the treatment of urgent dialysis patients can save more manpower
      and resources, and improve the efficiency of peritoneal dialysis. The study on the efficacy
      and safety of urgent dialysis lacks the precisely designed multi-center, prospective and
      controlled clinical trial, and APD only induces 3 days, it is difficult to really reflect the
      safety and effectiveness of APD. Therefore, it is of great practical significance to study
      the difference of safety, efficacy and cost-effectiveness between urgent PD and HD in a
      prospective, control and multicenter clinical trial. 206 ESRD uremia patients will involve in
      this multi-center, prospective and controlled clinical trial, the mode of urgent dialysis
      will choose by patient guided by nephrologist, the HD group will receive the standard
      traditional treatment: from induction HD to regular HD. The PD group will receive the APD
      daily. All patient will be monitor the physiological and biochemical marker for 14 day, and
      all adverse events and dead within 90days will collected to evaluated the safety, efficacy of
      the two urgent dialysis modes.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: the mode of urgent dialysis will choose by patient guided by nephrologist, the HD group will receive the standard traditional treatment: from induction HD to regular HD. The PD group will receive the APD daily.
primary purpose: Treatment
masking: None (Open Label)
measure: infective morbidity
time frame: At 14 days after the initiation of dialysis
description: peritonitis (APD), Bacteremia and catheter-related infections (APD and IHD)
measure: Mechanical complications morbidity
time frame: At 14 and 90 days after the initiation of dialysis
description: catheter leakage and migration (APD), catheter obstruction (IHD)， Exit site bleeding, pneumothorax, hernia
measure: dialysis related mortality
time frame: At 14 and 90 days after the initiation of dialysis
description: catheter-related:Sepsis, severe thromboembolic events (massive cerebral infarction, pulmonary embolism), arrhythmia (ventricular tachycardia, ventricular fibrillation),bleeding, Congestive heart failure and ischemic heart disease
measure: infective morbidity
time frame: At 90 days after the initiation of dialysis
description: peritonitis (APD), Bacteremia and catheter-related infections (APD and IHD)
arm group label: APD group
arm group type: Experimental
description: Subjects will receive PD catheter placement and subsequent automated peritoneal dialysis treatment
arm group label: IHD group
arm group type: Active Comparator
description: Subjects will receive un-tunneled hemodialysis catheter placement and subsequent hemodialysis treatment 3-4 times per week,2-4 hours each time.
intervention type: Procedure
intervention name: automated peritoneal dialysis
description: peritoneal dialysis administered by a cycler
arm group label: APD group
intervention type: Procedure
intervention name: IHD
description: HD 4hour 2-3times per week
arm group label: IHD group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Limeng Chen, MD
role: Principal Investigator
affiliation: Division of Nephrology, Peking Union Medical College Hospital
last name: Haiyun Wang, MD
phone: +86-13671063539
email: wanghaiyun62926@126.COM
last name: Peng Xia, MD
phone: +86-13811684903
email: 7-xp@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: China
responsible party type: Sponsor
sharing ipd: No
ipd description: To comply with laws in China, local regulations and hospital policy, IPD sharing might be restricted