<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/NCT02200120</url>
  </required_header>
  <id_info>
    <org_study_id>99904021982</org_study_id>
    <nct_id>NCT02200120</nct_id>
  </id_info>
  <brief_title>Evaluation of Catheter Placement for Renal Replacement Therapy in Patients With Acute Kidney Injury</brief_title>
  <official_title>Evaluation of Catheter Placement for Renal Replacement Therapy in Patients With Acute Kidney Injury- Assessment of Dialysis Adequacy and Infection Rates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the placement, timing, associated complications,&#xD;
      efficacy of temporary and tunneled catheters for renal replacement therapy in patient with&#xD;
      acute kidney injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to examine the placement, timing, associated complications,&#xD;
      efficacy of temporary and tunneled catheters for renal replacement therapy in patient with&#xD;
      acute kidney injury. In particular, we will be assessing renal replacement adequacy for&#xD;
      patients on dialysis and continuous veno-venous hemofiltration by monitoring urea reduction&#xD;
      ratios, venous and arterial pressures. We will also be monitoring infection rates. We will&#xD;
      compare these outcomes in patients receiving tunneled catheters and patients receiving&#xD;
      temporary catheters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Dialysis adequacy</measure>
    <time_frame>up to 7d after starting renal replacement therapy</time_frame>
    <description>Adequacy will be measured using urea reduction ratio for patients on intermittent hemodialysis. For continuous renal replacement therapy, we will record the maximum blood flow rate achievable. These measurements/recordings will be made on average within 1-3 days of starting therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>blood stream infection rates</measure>
    <time_frame>within 30d of catheter placement</time_frame>
    <description>Patients will be followed throughout their hospitalization, which can range from a few days to several weeks. Bloodstream infections within 30d of catheter placement will be recorded.</description>
  </secondary_outcome>
  <enrollment type="Actual">150</enrollment>
  <condition>Acute Kidney Injury</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to the hospital with acute kidney injury requiring renal replacement&#xD;
        therapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted to the hospital with acute kidney injury requiring renal replacement&#xD;
             therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  End stage renal disease&#xD;
&#xD;
          -  Chronic kidney disease 5 progression to end stage renal disease&#xD;
&#xD;
          -  Outside hospital catheter placement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sushrut Waikar, MD, MHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mallika L Mendu</last_name>
    <role>Study Director</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>July 20, 2015</last_update_submitted>
  <last_update_submitted_qc>July 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Sushrut S Waikar</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT02200120
org study id: 99904021982
nct id: NCT02200120
lead sponsor: 
has dmc: Yes
The purpose of this study is to examine the placement, timing, associated complications,
      efficacy of temporary and tunneled catheters for renal replacement therapy in patient with
      acute kidney injury.
The purpose of this study is to examine the placement, timing, associated complications,
      efficacy of temporary and tunneled catheters for renal replacement therapy in patient with
      acute kidney injury. In particular, we will be assessing renal replacement adequacy for
      patients on dialysis and continuous veno-venous hemofiltration by monitoring urea reduction
      ratios, venous and arterial pressures. We will also be monitoring infection rates. We will
      compare these outcomes in patients receiving tunneled catheters and patients receiving
      temporary catheters.
observational model: Cohort
time perspective: Prospective
measure: Dialysis adequacy
time frame: up to 7d after starting renal replacement therapy
description: Adequacy will be measured using urea reduction ratio for patients on intermittent hemodialysis. For continuous renal replacement therapy, we will record the maximum blood flow rate achievable. These measurements/recordings will be made on average within 1-3 days of starting therapy.
measure: blood stream infection rates
time frame: within 30d of catheter placement
description: Patients will be followed throughout their hospitalization, which can range from a few days to several weeks. Bloodstream infections within 30d of catheter placement will be recorded.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Sushrut Waikar, MD, MHS
role: Principal Investigator
affiliation: Brigham and Women's Hospital
last name: Mallika L Mendu
role: Study Director
affiliation: Brigham and Women's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Sushrut S Waikar
investigator title: Associate Professor
mesh term: Acute Kidney Injury
mesh term: Wounds and Injuries