<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/NCT01683734</url>
  </required_header>
  <id_info>
    <org_study_id>Nephro11-021-1</org_study_id>
    <nct_id>NCT01683734</nct_id>
  </id_info>
  <brief_title>Assessing Renal Function in Patients With an Antibiotic Laden Spacer</brief_title>
  <official_title>Nephrotoxicity Following 2-Stage Exchange With Associated Antibiotic Laden Spacer in Patients With Infected Total Hip/Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central DuPage Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central DuPage Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to monitor the renal function of patients who have an antibiotic&#xD;
      laden spacer in place to treat an infected hip or knee arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2012</start_date>
  <primary_completion_date type="Anticipated">December 2019</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>Development of acute renal insufficiency or acute renal failure measured by changes in laboratory values assessing renal function</measure>
    <time_frame>subjects will be followed during the time the antibiotic spacer is in place which is approximately 8 weeks</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Infected Total Hip or Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Renal Function Observation</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients with an infected hip or knee arthroplasty scheduled to undergo a 2-stage resection&#xD;
        surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All patients undergoing a hip or knee resection arthroplasty by the primary&#xD;
             investigator&#xD;
&#xD;
          2. Ages 18+&#xD;
&#xD;
          3. Ability to adhere to follow up schedule&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unable to give informed consent&#xD;
&#xD;
          2. Age &lt;18&#xD;
&#xD;
          3. Previous history of infected Total Knee Arthroplasty or Total Hip Arthroplasty&#xD;
&#xD;
          4. History of renal failure or impaired renal function&#xD;
&#xD;
          5. Allergies to aminoglycosides or Vancomycin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Scott Sporer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>RUSH University Medical Center; Central DuPage Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stefanie Miller, BS</last_name>
    <phone>630-933-6254</phone>
    <email>Stefanie.Miller@CadenceHealth.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Judy Guerreiro, RN</last_name>
    <phone>630-933-2941</phone>
    <email>Judy.Guerreiro@CadenceHealth.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>RUSH University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Central DuPage Hospital</name>
      <address>
        <city>Winfield</city>
        <state>Illinois</state>
        <zip>60190</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Scott Sporer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>February 3, 2015</last_update_submitted>
  <last_update_submitted_qc>February 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01683734
org study id: Nephro11-021-1
nct id: NCT01683734
lead sponsor: 
has dmc: No
The purpose of this study is to monitor the renal function of patients who have an antibiotic
      laden spacer in place to treat an infected hip or knee arthroplasty.
observational model: Cohort
time perspective: Prospective
measure: Development of acute renal insufficiency or acute renal failure measured by changes in laboratory values assessing renal function
time frame: subjects will be followed during the time the antibiotic spacer is in place which is approximately 8 weeks
arm group label: Renal Function Observation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Scott Sporer, MD
role: Principal Investigator
affiliation: RUSH University Medical Center; Central DuPage Hospital
last name: Stefanie Miller, BS
phone: 630-933-6254
email: Stefanie.Miller@CadenceHealth.org
last name: Judy Guerreiro, RN
phone: 630-933-2941
email: Judy.Guerreiro@CadenceHealth.org
facility: 
status: Recruiting
facility: 
status: Recruiting
investigator: 
country: United States
responsible party type: Sponsor