<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/NCT02207751</url>
  </required_header>
  <id_info>
    <org_study_id>STH18109</org_study_id>
    <nct_id>NCT02207751</nct_id>
  </id_info>
  <brief_title>Improving Outcomes in Peritoneal Dialysis</brief_title>
  <official_title>Improving Outcomes in Peritoneal Dialysis: Identification and Characterization of Optimal Clinical Practice to Enhance Peritoneal Dialysis Catheter Functionality, Minimize Access-related Complications and Promote Peritoneal Dialysis as an Initiating Therapeutic Modality for Chronic Kidney Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baxter Healthcare Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sheffield Teaching Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective is to understand the best way to place Peritoneal Dialysis (PD) catheters, and&#xD;
      the best way to collect data regarding their function in England, Wales and Northern Ireland.&#xD;
&#xD;
      Phase 1: We will carry out a detailed examination of existing returned pilot data with&#xD;
      emphasis on data fields with poor data completeness and perform root cause analysis, and&#xD;
      assess deficiencies in data field definition to identify improvements to be implemented. We&#xD;
      will construct and disseminate electronic survey material to all study centres with targeted&#xD;
      visits by the Principle Investigator undertaken. These visits will facilitate insight into&#xD;
      local organization of data collection including interaction with designated individuals&#xD;
      responsible for data returns. PD training days will be organized with emphasis on clinical&#xD;
      practice feedback utilizing data acquired in the initial phases. Hospital Episode Statistics&#xD;
      will be linked to existing acquired PD patient information to ensure the accuracy of&#xD;
      collected data. An online data acquisition system will be developed to allow direct data&#xD;
      entry from centres.&#xD;
&#xD;
      Phase 2: On-going and sustained data acquisition performed on a prospective basis.&#xD;
&#xD;
      Phase 3: Primary data analysis including clinical practice variation in England, Wales and&#xD;
      Northern Ireland to identify site specific PD catheter functionality variation. Additionally,&#xD;
      patient and site specific characteristics that predict clinical outcomes in PD will be&#xD;
      identified and characterised.&#xD;
&#xD;
      Phase 4: Clinical guidelines will be developed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">August 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2016</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>Peritoneal dialysis catheter &quot;survival&quot; (sustained function) at 365 days post-insertion (insertion date)</measure>
    <time_frame>1 Year</time_frame>
    <description>Functional (mechanical) catheter failure&#xD;
Complication induced catheter failure - Infection, Hemorrhage, Dialysate Leakage &amp; Bowel Perforation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to catheter failure</measure>
    <time_frame>Within 1 Year</time_frame>
    <description>Catheter failure time (days elapsed from insertion to failure &lt;365 days)&#xD;
Catheter failure time (days elapsed from insertion to failure &gt;365 days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Missing Data</measure>
    <time_frame>Baseline &amp; 1 Year</time_frame>
    <description>Missing mandatory data fields</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality (all cause)</measure>
    <time_frame>Within 1 Year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Co-morbid Hospitalization Events</measure>
    <time_frame>Within 1 Year</time_frame>
    <description>Non-fatal medical events requiring hospitalization, excluding PD related hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection events not resulting in catheter failure</measure>
    <time_frame>Within 1 Year</time_frame>
    <description>Exit site / tunnel infection (early): suspected or definite infection around catheter exit site requiring intervention up to 2 weeks following catheter insertion&#xD;
Exit site / tunnel infection (late): suspected or definite infection around catheter exit site requiring intervention after 2 weeks following catheter insertion&#xD;
Peritonitis (early): peritonitis within 2 weeks of catheter insertion&#xD;
Peritonitis (late): peritonitis after 2 weeks following catheter insertion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leak events not resulting in catheter failure</measure>
    <time_frame>Within 1 Year</time_frame>
    <description>Catheter leak events (early): suspected or definite catheter site leak requiring intervention up to 2 weeks following catheter insertion&#xD;
Catheter leak events (late): suspected or definite catheter site leak requiring intervention after 2 weeks following catheter insertion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modality change</measure>
    <time_frame>Within 1 Year</time_frame>
    <description>Change of modality from PD to any other form of renal replacement therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catheter non-usage</measure>
    <time_frame>Within 1 Year</time_frame>
    <description>Catheters inserted but not used for reasons other than failed initial therapy (e.g. Moncrieff)</description>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <condition>Peritoneal Dialysis Access</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All incident patients requiring peritoneal dialysis for end stage renal disease of all&#xD;
        etiologies.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any adult (16 years or over) patient requiring first PD catheter placement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient less than 16 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Victoria R Briggs, MBBS BMedSci</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheffield Teaching Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>April 13, 2016</last_update_submitted>
  <last_update_submitted_qc>April 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Kidney Disease</keyword>
  <keyword>Peritoneal Dialysis Access</keyword>
  <keyword>Peritoneal Dialysis Catheter</keyword>
  <keyword>Catheter Function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, 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/NCT02207751
org study id: STH18109
nct id: NCT02207751
lead sponsor: 
collaborator: 
has dmc: Yes
The objective is to understand the best way to place Peritoneal Dialysis (PD) catheters, and
      the best way to collect data regarding their function in England, Wales and Northern Ireland.

      Phase 1: We will carry out a detailed examination of existing returned pilot data with
      emphasis on data fields with poor data completeness and perform root cause analysis, and
      assess deficiencies in data field definition to identify improvements to be implemented. We
      will construct and disseminate electronic survey material to all study centres with targeted
      visits by the Principle Investigator undertaken. These visits will facilitate insight into
      local organization of data collection including interaction with designated individuals
      responsible for data returns. PD training days will be organized with emphasis on clinical
      practice feedback utilizing data acquired in the initial phases. Hospital Episode Statistics
      will be linked to existing acquired PD patient information to ensure the accuracy of
      collected data. An online data acquisition system will be developed to allow direct data
      entry from centres.

      Phase 2: On-going and sustained data acquisition performed on a prospective basis.

      Phase 3: Primary data analysis including clinical practice variation in England, Wales and
      Northern Ireland to identify site specific PD catheter functionality variation. Additionally,
      patient and site specific characteristics that predict clinical outcomes in PD will be
      identified and characterised.

      Phase 4: Clinical guidelines will be developed.
observational model: Cohort
time perspective: Prospective
measure: Peritoneal dialysis catheter "survival" (sustained function) at 365 days post-insertion (insertion date)
time frame: 1 Year
description: Functional (mechanical) catheter failure
Complication induced catheter failure - Infection, Hemorrhage, Dialysate Leakage & Bowel Perforation
measure: Time to catheter failure
time frame: Within 1 Year
description: Catheter failure time (days elapsed from insertion to failure <365 days)
Catheter failure time (days elapsed from insertion to failure >365 days)
measure: Missing Data
time frame: Baseline & 1 Year
description: Missing mandatory data fields
measure: Mortality (all cause)
time frame: Within 1 Year
measure: Co-morbid Hospitalization Events
time frame: Within 1 Year
description: Non-fatal medical events requiring hospitalization, excluding PD related hospitalization
measure: Infection events not resulting in catheter failure
time frame: Within 1 Year
description: Exit site / tunnel infection (early): suspected or definite infection around catheter exit site requiring intervention up to 2 weeks following catheter insertion
Exit site / tunnel infection (late): suspected or definite infection around catheter exit site requiring intervention after 2 weeks following catheter insertion
Peritonitis (early): peritonitis within 2 weeks of catheter insertion
Peritonitis (late): peritonitis after 2 weeks following catheter insertion
measure: Leak events not resulting in catheter failure
time frame: Within 1 Year
description: Catheter leak events (early): suspected or definite catheter site leak requiring intervention up to 2 weeks following catheter insertion
Catheter leak events (late): suspected or definite catheter site leak requiring intervention after 2 weeks following catheter insertion
measure: Modality change
time frame: Within 1 Year
description: Change of modality from PD to any other form of renal replacement therapy
measure: Catheter non-usage
time frame: Within 1 Year
description: Catheters inserted but not used for reasons other than failed initial therapy (e.g. Moncrieff)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Victoria R Briggs, MBBS BMedSci
role: Principal Investigator
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic