<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/NCT01684228</url>
  </required_header>
  <id_info>
    <org_study_id>0271-10-RMB-CTIL</org_study_id>
    <nct_id>NCT01684228</nct_id>
  </id_info>
  <brief_title>Impact of Hemodialysis on Exhaled Volatile Organic Compounds in End Stage Renal Disease</brief_title>
  <official_title>Impact of Hemodialysis on Exhaled Volatile Organic Compounds in End Stage Renal Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      End stage renal disease (ESRD) is a severe clinical state of irreversible loss of endogenous&#xD;
      kidney function, shortening life expectancy, if left untreated. In the state of ESRD, over&#xD;
      5000 uremic toxins are accumulated in the body causing dysfunction of various organ systems.&#xD;
      The survival of these patients depends on renal replacement therapies, such as hemodialysis&#xD;
      (HD), which artificially purifies the blood from toxins. The investigators assume that some&#xD;
      of the uremic toxins are also present in the patient's exhaled breath, and could be detected&#xD;
      by a non-invasive and highly sensitive test: a NA-NOSE artificial olfactory system. It is&#xD;
      based on analysis of volatile organic compounds (VOCs), a novel, non-invasive field in&#xD;
      medical diagnostics. The NA-NOSE is made from an array of nanosensors, and was developed by&#xD;
      our collaborator Dr. Hossam Haick (Chemical Engineering, Technion).&#xD;
&#xD;
      In the current study, the investigators utilize this technology to identify VOCs in the&#xD;
      exhaled breath of dialysis patients, and to characterize certain patterns of expression that&#xD;
      could potentially help in future monitoring of HD adequacy. The investigators plan to collect&#xD;
      150 breath samples from patients before and during dialysis, and from healthy subjects. All&#xD;
      participants provide a signed informed consent. Subsequently, analysis of samples will be&#xD;
      done at Dr. Haick's laboratory, using Gas-Chromatography/Mass-Spectrometry and parameters&#xD;
      extracted from each sensor response.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2010</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <enrollment type="Actual">37</enrollment>
  <condition>End Stage Renal Disease</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      exhaled breath&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Hemodialysis patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 Years and older&#xD;
&#xD;
          -  End stage renal disease receiving hemodialysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age under 18&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Malignancy&#xD;
&#xD;
          -  Infectious diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suheir Assady, MD, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Nephrology, Rambam-Health Care Campus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rambam Health Care Campus</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>September 10, 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>May 6, 2015</last_update_submitted>
  <last_update_submitted_qc>May 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>End stage renal disease</keyword>
  <keyword>hemodialysis</keyword>
  <keyword>breath test</keyword>
  <keyword>volatile organic compound</keyword>
  <keyword>dialysis adequacy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, 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/NCT01684228
org study id: 0271-10-RMB-CTIL
nct id: NCT01684228
lead sponsor: 
has dmc: No
End stage renal disease (ESRD) is a severe clinical state of irreversible loss of endogenous
      kidney function, shortening life expectancy, if left untreated. In the state of ESRD, over
      5000 uremic toxins are accumulated in the body causing dysfunction of various organ systems.
      The survival of these patients depends on renal replacement therapies, such as hemodialysis
      (HD), which artificially purifies the blood from toxins. The investigators assume that some
      of the uremic toxins are also present in the patient's exhaled breath, and could be detected
      by a non-invasive and highly sensitive test: a NA-NOSE artificial olfactory system. It is
      based on analysis of volatile organic compounds (VOCs), a novel, non-invasive field in
      medical diagnostics. The NA-NOSE is made from an array of nanosensors, and was developed by
      our collaborator Dr. Hossam Haick (Chemical Engineering, Technion).

      In the current study, the investigators utilize this technology to identify VOCs in the
      exhaled breath of dialysis patients, and to characterize certain patterns of expression that
      could potentially help in future monitoring of HD adequacy. The investigators plan to collect
      150 breath samples from patients before and during dialysis, and from healthy subjects. All
      participants provide a signed informed consent. Subsequently, analysis of samples will be
      done at Dr. Haick's laboratory, using Gas-Chromatography/Mass-Spectrometry and parameters
      extracted from each sensor response.
observational model: Case-Control
time perspective: Prospective
exhaled breath
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Suheir Assady, MD, Ph.D
role: Principal Investigator
affiliation: Department of Nephrology, Rambam-Health Care Campus
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic