<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/NCT02978378</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00006088</org_study_id>
    <nct_id>NCT02978378</nct_id>
  </id_info>
  <brief_title>Renal Biomarkers to Predict Recovery Following Venoarterial Extracorporeal Membrane Oxygenation</brief_title>
  <official_title>Renal Biomarkers to Predict Recovery Following Venoarterial Extracorporeal Membrane Oxygenation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Milton S. Hershey Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators objective is to assess the utility of renal biomarkers in predicting renal&#xD;
      recovery following institution of Venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO).&#xD;
      Tissue biomarkers of renal injury may provide a real-time indication of renal function and&#xD;
      the likelihood of renal recovery in patients having cardiogenic shock and requiring VA-ECMO.&#xD;
      In these patients, traditional markers of kidney function (urine output and serum Creatinine&#xD;
      level) do not accurately represent renal function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    insufficient patients to satisfy study protocol(s) inclusion criteria&#xD;
  </why_stopped>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">March 23, 2018</completion_date>
  <primary_completion_date type="Actual">March 23, 2018</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>renal biomarker levels</measure>
    <time_frame>through VA-ECMO decannulation, an average of 3 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>need for continuous renal replacement therapy at hospital discharge (Yes/No)</measure>
    <time_frame>measured at hospital discharge, an average of 2-3 months following initial hospital admission</time_frame>
    <description>The need for continuous renal replacement therapy at hospital discharge will be assessed using hospital medical records</description>
  </primary_outcome>
  <enrollment type="Actual">2</enrollment>
  <condition>Acute Kidney Injury</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>biomarker levels</intervention_name>
    <description>The level of the biomarker hyaluronic acid will be measured</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      urine and blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        patients with cardiogenic shock and acute kidney injury requiring continuous renal&#xD;
        replacement therapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age more than 18 years&#xD;
&#xD;
          -  refractory or advanced cardiogenic shock prior to institution of VA-ECMO&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of chronic kidney disease prior to cardiogenic shock, as defined by estimated&#xD;
             glomerular filtration rate (GFR) less than 60 mL per min&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  patient or surrogate is not fluent in English&#xD;
&#xD;
          -  Long-term immunosuppression&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anthony Bonavia</last_name>
    <role>Principal Investigator</role>
    <affiliation>Milton S. Hershey Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Milton S. Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>March 29, 2018</last_update_submitted>
  <last_update_submitted_qc>March 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>Anthony Bonavia</investigator_full_name>
    <investigator_title>Assistant 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>
  </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/NCT02978378
org study id: STUDY00006088
nct id: NCT02978378
lead sponsor: 
has dmc: No
The investigators objective is to assess the utility of renal biomarkers in predicting renal
      recovery following institution of Venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO).
      Tissue biomarkers of renal injury may provide a real-time indication of renal function and
      the likelihood of renal recovery in patients having cardiogenic shock and requiring VA-ECMO.
      In these patients, traditional markers of kidney function (urine output and serum Creatinine
      level) do not accurately represent renal function.
observational model: Cohort
time perspective: Prospective
measure: renal biomarker levels
time frame: through VA-ECMO decannulation, an average of 3 weeks
measure: need for continuous renal replacement therapy at hospital discharge (Yes/No)
time frame: measured at hospital discharge, an average of 2-3 months following initial hospital admission
description: The need for continuous renal replacement therapy at hospital discharge will be assessed using hospital medical records
intervention type: Other
intervention name: biomarker levels
description: The level of the biomarker hyaluronic acid will be measured
urine and blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Anthony Bonavia
role: Principal Investigator
affiliation: Milton S. Hershey Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: Anthony Bonavia
investigator title: Assistant Professor
mesh term: Acute Kidney Injury
sharing ipd: Undecided