<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/NCT03801044</url>
  </required_header>
  <id_info>
    <org_study_id>1908</org_study_id>
    <nct_id>NCT03801044</nct_id>
  </id_info>
  <brief_title>Lung Ultrasound in PD Patients</brief_title>
  <acronym>LUSiPD</acronym>
  <official_title>Comparison of Lung Ultrasound and Other Volumetric Methods in Peritoneal Dialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sisli Hamidiye Etfal Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sisli Hamidiye Etfal Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although many alternative methods are present, maintaining ideal volume status in peritoneal&#xD;
      dialysis (PD) patients still rely on clinical evaluation due to lack of an evidence based&#xD;
      method. Lung ultrasound (LUS) is a new method for evaluation of hidden congestion in this&#xD;
      group. LUS findings and its relationship with other volumetric methods are investigated in&#xD;
      this study. LUS was performed to all peritoneal dialysis patients and compared with symptoms&#xD;
      of hypervolemia, physical examination, vascular endothelial growth factor-C (VEGF-C) and&#xD;
      N-terminal pro-brain natriuretic peptide levels, chest radiography, echocardiography,&#xD;
      bioelectrical impedance analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Maintaining volume control is crucial in all renal replacement therapy modalities. Fluid&#xD;
      overload is associated with increased mortality both in hemodialysis patients and peritoneal&#xD;
      dialysis (PD) patients although peritoneal dialysis has the advantage of better preservation&#xD;
      of residual renal function compared to hemodialysis. Many methods have been used to fine tune&#xD;
      the volume status of patients including physical examination, chest radiography, blood&#xD;
      pressure, laboratory parameters, echocardiography, bioelectrical impedance analysis (BIA),&#xD;
      ultrasound for lung.&#xD;
&#xD;
      Symptoms of hypervolemia are mainly paroxysmal nocturnal dyspnea, orthopnea, edema, dyspnea&#xD;
      on exertion. On physical examination, hypertension or hypotension, third heart sound, jugular&#xD;
      venous distension, rales, edema can be seen. Pulmonary venous congestion, cardiomegaly,&#xD;
      interstitial edema, alveolar edema, pleural effusion can be seen on chest radiographies.&#xD;
&#xD;
      Level of N-terminal pro-brain natriuretic peptide (NT-proBNP) increases upon stretching of&#xD;
      cardiac myocytes. This is accepted as a reflection of volume status. There are a few studies&#xD;
      in which NT-proBNP was found as a useful marker for hypervolemia both in hemodialysis and&#xD;
      peritoneal dialysis population.&#xD;
&#xD;
      Vascular endothelial growth factor-C (VEGF-C) is an osmosensitive gene product secreted by&#xD;
      macrophages through activation of tonicity-responsive enhancer binding protein found in&#xD;
      mononuclear phagocyte system cells infiltrating the interstitium. The result is hypertonic&#xD;
      sodium accumulation in the skin which is accepted as a buffer mechanism maintaining blood&#xD;
      pressure homeostasis. Serum VEGF-C levels had been found as a promising marker of&#xD;
      hypervolemia in a hemodialysis patient cohort by a recent study.&#xD;
&#xD;
      Echocardiography has been used extensively in dialysis patients in which a number of&#xD;
      parameters have been measured. Bioelectrical impedance analysis (BIA) is another non-invasive&#xD;
      bedside method for the evaluation of volume status.&#xD;
&#xD;
      Lung ultrasound (LUS) is a technique that has become popular in nephrology recently. &quot;B&#xD;
      lines&quot; or &quot;lung comets&quot; are the reverberation artifacts arising from the pleural line. They&#xD;
      are produced due to thickened subpleural interlobular septa by edema.&#xD;
&#xD;
      The gold standard for volume assessment is isotope dilution and neutron activation analysis&#xD;
      methods which are only limited to research activities. The best widely accepted,&#xD;
      non-invasive, practical, easy to access method has not been decided yet. Moreover evidence is&#xD;
      quite scarce for the peritoneal dialysis than hemodialysis or normal renal functioning group.&#xD;
      Lung ultrasound is the most recent promising method for volume control.&#xD;
&#xD;
      The investigators aimed to define lung ultrasound findings in our peritoneal dialysis cohort&#xD;
      and its relation with other volumetric parameters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">September 1, 2018</completion_date>
  <primary_completion_date type="Actual">September 1, 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Association Between Number of Kerley B Lines by Ultrasound and Serum VEGF-C Level (pg/ml) by Enzyme-linked Immunosorbent Assay</measure>
    <time_frame>4 months</time_frame>
    <description>Assessing the relationship between number of Kerley B lines by ultrasound and serum VEGF-C level (pg/ml) by enzyme-linked immunosorbent assay</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Association Between Number of Kerley B Lines by Ultrasound and Dyspnea by Questionnaire</measure>
    <time_frame>4 months</time_frame>
    <description>Assessing the relationship between number of Kerley B lines by ultrasound and dyspnea by questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association Between Number of Kerley B Lines by Ultrasound and Class of New York Heart Association Classification</measure>
    <time_frame>4 months</time_frame>
    <description>Assessing the relationship between number of Kerley B lines by ultrasound and class of New York Heart Association Classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association Between Number of Kerley B Lines by Ultrasound and Presence of Third Sound/Pretibial Edema by Auscultation/Edema by Physical Examination</measure>
    <time_frame>4 months</time_frame>
    <description>Assessing the relationship between number of Kerley B lines by ultrasound and presence of third sound (S3) by auscultation/edema by physical examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association Between Number of Kerley B Lines by Ultrasound Left Ventricle End Diastolic Diameter (mm) Obtained by the Cardiologist With Echocardiography</measure>
    <time_frame>4 months</time_frame>
    <description>Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle end diastolic diameter (mm) obtained by the cardiologist with echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association Between Number of Kerley B Lines by Ultrasound Interventricular Septum Thickness (mm) Obtained by the Cardiologist With Echocardiography</measure>
    <time_frame>4 months</time_frame>
    <description>Assessing the relationship between number of Kerley B by ultrasound and interventricular septum thickness (mm) (mm) obtained by the cardiologist with echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association Between Number of Kerley B by Ultrasound and Posterior Wall Thickness (mm) Obtained by the Cardiologist With Echocardiography</measure>
    <time_frame>4 months</time_frame>
    <description>Assessing the relationship between number of Kerley B by ultrasound and posterior wall thickness (mm) obtained by the cardiologist with echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association Between Number of Kerley B Lines by Ultrasound and Ejection Fraction (%) Obtained by the Cardiologist With Echocardiography</measure>
    <time_frame>4 months</time_frame>
    <description>Assessing the relationship between number of Kerley B lines by ultrasound and ejection fraction (%) obtained by the cardiologist with echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle End Diastolic Volume (ml) Obtained by the Cardiologist With Echocardiography</measure>
    <time_frame>4 months</time_frame>
    <description>Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle end diastolic volume (ml) obtained by the cardiologist with echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association Between Number of Kerley B Lines by Ultrasound and Left Atrial Volume (ml) Obtained by the Cardiologist With Echocardiography</measure>
    <time_frame>4 months</time_frame>
    <description>Assessing the relationship between number of Kerley B lines by ultrasound and left atrial volume (ml) obtained by the cardiologist with echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle Mass Index (g/m2) Obtained by the Cardiologist With Echocardiography</measure>
    <time_frame>4 months</time_frame>
    <description>Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle mass index (g/m2) obtained by the cardiologist with echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle Filling Velocity (cm/Sec) Obtained by the Cardiologist With Echocardiography</measure>
    <time_frame>4 months</time_frame>
    <description>Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle filling velocity (cm/sec) obtained by the cardiologist with echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association Between Number of Kerley B Lines by Ultrasound and Early Mitral Inflow Velocity and Mitral Annular Early Diastolic Velocity (E/E') Obtained by the Cardiologist With Echocardiography</measure>
    <time_frame>4 months</time_frame>
    <description>Assessing the relationship between number of Kerley B lines by ultrasound and early mitral inflow velocity and mitral annular early diastolic velocity (E/E') obtained by the cardiologist with echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association Between Number of Kerley B Lines by Ultrasound and Pulmonary Artery Systolic Pressure (mmHg) Obtained by the Cardiologist With Echocardiography</measure>
    <time_frame>4 months</time_frame>
    <description>Assessing the relationship between number of Kerley B lines by ultrasound and pulmonary artery systolic pressure (mmHg) obtained by the cardiologist with echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association Between Number of Kerley B Lines by Ultrasound and Bioimpedance Analysis [Assessed With the Body Composition Monitor; Normovolemic if Their Result Between -1,1 lt and 1,1 lt)</measure>
    <time_frame>4 months</time_frame>
    <description>Assessing the relationship between number of Kerley B lines by ultrasound and bioimpedance analysis [assessed with the body composition monitor; normovolemic if their result between -1,1 lt and 1,1 lt)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association Between Number of Kerley B Lines by Ultrasound and NT-proBNP Level (pg/ml) by Elecsys proBNP Immunoassay</measure>
    <time_frame>4 months</time_frame>
    <description>Assessing the relationship between number of Kerley B lines by ultrasound and NT-proBNP level (pg/ml) by Elecsys proBNP Immunoassay</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">23</enrollment>
  <condition>Peritoneal Dialysis</condition>
  <condition>Hypervolemia</condition>
  <condition>VEGF Overexpression</condition>
  <arm_group>
    <arm_group_label>PD patients</arm_group_label>
    <description>All PD patients treated in out unit were enrolled.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>NT-BNP, VEGF</intervention_name>
    <description>VEGF-C levels were measured in the serum samples. R&amp;D Systems kit (Minneapolis, MN) (Catalog Number DVEC00) was used for the assays according to the user instructions. NT-proBNP was measured on the Elecsys 2010 analyzer (Elecsys proBNP Immunoassay; Roche Diagnostics).</description>
    <arm_group_label>PD patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Echocardiography</intervention_name>
    <description>Transthoracic echocardiography was performed by the same cardiologist blinded to all other parameters. It was done while abdomen was empty. LV end diastolic diameter (mm), interventricular septum thickness (mm), posterior wall thickness (mm), ejection fraction (%), left ventricle end diastolic volume (ml), left atrial volume (ml), left ventricle mass index (LVMI) (g/m2), left ventricle filling velocity(cm/sec), E/E' ratio, pulmonary artery systolic pressure (mm Hg) were the parameters taken by echocardiography</description>
    <arm_group_label>PD patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Chest Radiography</intervention_name>
    <description>All radiographies were taken when the patient was standing erect position during deep inhalation. They were reported by an expert radiologist blinded to clinical data. Films taken at supine position or during exhalation were excluded. Chest radiographies were classified into 3 stages to reflect degree of hypervolemia. Stage 1 was redistribution defined as increased artery-to-bronchus ratio in the upper and middle lobes. Stage 2 was interstitial edema evident by Kerley B lines and peribronchial cuffing. Stage 3 was alveolar edema phase perihilar consolidation and air bronchograms, pleural fluid, increased width of the vascular pedicle, enlarged cardiac silhouette.</description>
    <arm_group_label>PD patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Lung Ultrasound</intervention_name>
    <description>It was performed by 28 area method which contains ultrasound examination from second to fifth intercostals spaces at parasternal region, midclavicular line, anterior and mid axillary lines. Lung ultrasound had been done by same radiologist who was an expertise in ultrasonography blinded to all other parameters. It was performed by 1,6 megaHertz convex probe when patient lying at the supine position.</description>
    <arm_group_label>PD patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Bioelectrical Impedence Analysis</intervention_name>
    <description>The Body Composition Monitor (BCM) (type 0BJA1394, Fresenius Medical Care AG &amp; Co. KGaA, D-61343 Bad Homburg) was used for assessment of hydration status in patients. Peritoneal cavities were free of intraperitoneal fluid during measurement. Patients were accepted as normovolemic if their result were between -1.1lt and 1.1 lt.</description>
    <arm_group_label>PD patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum samples for levels of vascular endothelial growth factor and N-terminal pro-brain&#xD;
      natriuretic peptide&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All peritoneal dialysis patients in the clinic have been invited to the study. Twenty three&#xD;
        patients were enrolled to the study. Two patients excluded from study because of&#xD;
        immobility.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years old,&#xD;
&#xD;
          -  History of PD more than 3 months,&#xD;
&#xD;
          -  Providing written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 18 years old,&#xD;
&#xD;
          -  Unwilling to participate to the study,&#xD;
&#xD;
          -  Immobile patients unable to perform test in the same day,&#xD;
&#xD;
          -  History of PD less than 3 months,&#xD;
&#xD;
          -  Presence of active infection,&#xD;
&#xD;
          -  History of lung cancer and/or operations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Mustafa Sevinc</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <results_first_submitted>February 7, 2019</results_first_submitted>
  <results_first_submitted_qc>March 17, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 31, 2020</results_first_posted>
  <last_update_submitted>March 31, 2020</last_update_submitted>
  <last_update_submitted_qc>March 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sisli Hamidiye Etfal Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Nuri Baris Hasbal</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03801044/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>All peritoneal dialysis patients in Sisli Hamidiye Etfal Training and Research Hospital, Nephrology Outpatient Clinic, Istanbul, Turkey have been invited to the study between May and September 2018.</recruitment_details>
      <pre_assignment_details>Total 23 patients accepted to participate in the study, but two of them were excluded because of immobility and not being capable of proceeding with the diagnostic tests</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>PD Patients</title>
          <description>21 PD patients treated in out unit were enrolled.&#xD;
NT-BNP, VEGF: VEGF-C levels were measured in the serum samples. R&amp;D Systems kit (Minneapolis, MN) (Catalog Number DVEC00) was used for the assays according to the user instructions. NT-proBNP was measured on the Elecsys 2010 analyzer (Elecsys proBNP Immunoassay; Roche Diagnostics).&#xD;
Echocardiography: Transthoracic echocardiography was performed by the same cardiologist blinded to all other parameters. It was done while abdomen was empty. LV end diastolic diameter (mm), interventricular septum thickness (mm), posterior wall thickness (mm), ejection fraction (%), left ventricle end diastolic volume (ml), left atrial volume (ml), left ventricle mass index (LVMI) (g/m2), left ventricle filling velocity(cm/sec), E/E' ratio, pulmonary artery systolic pressure (mm Hg) were the parameters taken by echocardiography&#xD;
Chest Radiography: All radiographies were taken when the patient was standing erect position during deep inhalation. They</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PD Patients</title>
          <description>21 PD patients treated in out unit were enrolled.&#xD;
NT-BNP, VEGF: VEGF-C levels were measured in the serum samples. R&amp;D Systems kit (Minneapolis, MN) (Catalog Number DVEC00) was used for the assays according to the user instructions. NT-proBNP was measured on the Elecsys 2010 analyzer (Elecsys proBNP Immunoassay; Roche Diagnostics).&#xD;
Echocardiography: Transthoracic echocardiography was performed by the same cardiologist blinded to all other parameters. It was done while abdomen was empty. LV end diastolic diameter (mm), interventricular septum thickness (mm), posterior wall thickness (mm), ejection fraction (%), left ventricle end diastolic volume (ml), left atrial volume (ml), left ventricle mass index (LVMI) (g/m2), left ventricle filling velocity(cm/sec), E/E' ratio, pulmonary artery systolic pressure (mm Hg) were the parameters taken by echocardiography&#xD;
Chest Radiography: All radiographies were taken when the patient was standing erect position during deep inhalation. They</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Turkey</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Etiology of End-Stage Renal Disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hypertension</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Diabetes Mellitus</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Familial Mediterrenean Fever</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Focal Segmental glomerulosclerosis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ig A Nephropathy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Tuberous Sclerosis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of PD, months</title>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22" lower_limit="13" upper_limit="49.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PD modality, CAPD (%)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Peritoneum Transport Type</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Low</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Low-medium</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High-medium</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Association Between Number of Kerley B Lines by Ultrasound and Serum VEGF-C Level (pg/ml) by Enzyme-linked Immunosorbent Assay</title>
        <description>Assessing the relationship between number of Kerley B lines by ultrasound and serum VEGF-C level (pg/ml) by enzyme-linked immunosorbent assay</description>
        <time_frame>4 months</time_frame>
        <population>All peritoneal dialysis patients in the clinic invited to the study. Two patients were excluded because of immobility</population>
        <group_list>
          <group group_id="O1">
            <title>PD Patients</title>
            <description>21 PD patients treated in out unit were enrolled.</description>
          </group>
        </group_list>
        <measure>
          <title>Association Between Number of Kerley B Lines by Ultrasound and Serum VEGF-C Level (pg/ml) by Enzyme-linked Immunosorbent Assay</title>
          <description>Assessing the relationship between number of Kerley B lines by ultrasound and serum VEGF-C level (pg/ml) by enzyme-linked immunosorbent assay</description>
          <population>All peritoneal dialysis patients in the clinic invited to the study. Two patients were excluded because of immobility</population>
          <units>ng/ml</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All patients</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.29" lower_limit="0.23" upper_limit="0.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Line ≤ 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25" lower_limit="0.21" upper_limit="0.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Line &gt; 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" lower_limit="0.27" upper_limit="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.039</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Association Between Number of Kerley B Lines by Ultrasound and Dyspnea by Questionnaire</title>
        <description>Assessing the relationship between number of Kerley B lines by ultrasound and dyspnea by questionnaire</description>
        <time_frame>4 months</time_frame>
        <population>PD patients (n=21)</population>
        <group_list>
          <group group_id="O1">
            <title>PD Patients</title>
            <description>All PD patients except for two patients who were immobile to adhere to diagnostic tests (n=21).</description>
          </group>
        </group_list>
        <measure>
          <title>Association Between Number of Kerley B Lines by Ultrasound and Dyspnea by Questionnaire</title>
          <description>Assessing the relationship between number of Kerley B lines by ultrasound and dyspnea by questionnaire</description>
          <population>PD patients (n=21)</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>B Lines ≤ 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B lines &gt; 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Association Between Number of Kerley B Lines by Ultrasound and Class of New York Heart Association Classification</title>
        <description>Assessing the relationship between number of Kerley B lines by ultrasound and class of New York Heart Association Classification</description>
        <time_frame>4 months</time_frame>
        <population>PD patients (n=21)</population>
        <group_list>
          <group group_id="O1">
            <title>PD Patients</title>
            <description>All PD patients except two patients who were immobile for adhering to diagnostic tests.</description>
          </group>
        </group_list>
        <measure>
          <title>Association Between Number of Kerley B Lines by Ultrasound and Class of New York Heart Association Classification</title>
          <description>Assessing the relationship between number of Kerley B lines by ultrasound and class of New York Heart Association Classification</description>
          <population>PD patients (n=21)</population>
          <units>percentage of NYHA Class 1</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>B Lines ≤ 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B lines &gt; 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Association Between Number of Kerley B Lines by Ultrasound and Presence of Third Sound/Pretibial Edema by Auscultation/Edema by Physical Examination</title>
        <description>Assessing the relationship between number of Kerley B lines by ultrasound and presence of third sound (S3) by auscultation/edema by physical examination</description>
        <time_frame>4 months</time_frame>
        <population>PD patients (n=21)</population>
        <group_list>
          <group group_id="O1">
            <title>PD Patients</title>
            <description>PD patients (n=21)</description>
          </group>
        </group_list>
        <measure>
          <title>Association Between Number of Kerley B Lines by Ultrasound and Presence of Third Sound/Pretibial Edema by Auscultation/Edema by Physical Examination</title>
          <description>Assessing the relationship between number of Kerley B lines by ultrasound and presence of third sound (S3) by auscultation/edema by physical examination</description>
          <population>PD patients (n=21)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>B Lines ≤ 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B lines &gt; 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Association Between Number of Kerley B Lines by Ultrasound Left Ventricle End Diastolic Diameter (mm) Obtained by the Cardiologist With Echocardiography</title>
        <description>Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle end diastolic diameter (mm) obtained by the cardiologist with echocardiography</description>
        <time_frame>4 months</time_frame>
        <population>PD patients (n=21)</population>
        <group_list>
          <group group_id="O1">
            <title>PD Patients</title>
            <description>PD Patients (n=21)</description>
          </group>
        </group_list>
        <measure>
          <title>Association Between Number of Kerley B Lines by Ultrasound Left Ventricle End Diastolic Diameter (mm) Obtained by the Cardiologist With Echocardiography</title>
          <description>Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle end diastolic diameter (mm) obtained by the cardiologist with echocardiography</description>
          <population>PD patients (n=21)</population>
          <units>cm</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>B Lines ≤ 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.75" lower_limit="4.12" upper_limit="5.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B lines &gt; 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" lower_limit="4.1" upper_limit="4.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Association Between Number of Kerley B Lines by Ultrasound Interventricular Septum Thickness (mm) Obtained by the Cardiologist With Echocardiography</title>
        <description>Assessing the relationship between number of Kerley B by ultrasound and interventricular septum thickness (mm) (mm) obtained by the cardiologist with echocardiography</description>
        <time_frame>4 months</time_frame>
        <population>PD patients (n=21)</population>
        <group_list>
          <group group_id="O1">
            <title>PD Patients</title>
            <description>PD patients (n=21)</description>
          </group>
        </group_list>
        <measure>
          <title>Association Between Number of Kerley B Lines by Ultrasound Interventricular Septum Thickness (mm) Obtained by the Cardiologist With Echocardiography</title>
          <description>Assessing the relationship between number of Kerley B by ultrasound and interventricular septum thickness (mm) (mm) obtained by the cardiologist with echocardiography</description>
          <population>PD patients (n=21)</population>
          <units>cm</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>B Lines ≤ 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.9" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B lines &gt; 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.85" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Association Between Number of Kerley B by Ultrasound and Posterior Wall Thickness (mm) Obtained by the Cardiologist With Echocardiography</title>
        <description>Assessing the relationship between number of Kerley B by ultrasound and posterior wall thickness (mm) obtained by the cardiologist with echocardiography</description>
        <time_frame>4 months</time_frame>
        <population>PD patients (n=21)</population>
        <group_list>
          <group group_id="O1">
            <title>PD Patients</title>
            <description>PD patients (n=21)</description>
          </group>
        </group_list>
        <measure>
          <title>Association Between Number of Kerley B by Ultrasound and Posterior Wall Thickness (mm) Obtained by the Cardiologist With Echocardiography</title>
          <description>Assessing the relationship between number of Kerley B by ultrasound and posterior wall thickness (mm) obtained by the cardiologist with echocardiography</description>
          <population>PD patients (n=21)</population>
          <units>cm</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>B Lines ≤ 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.9" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B lines &gt; 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" lower_limit="0.85" upper_limit="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Association Between Number of Kerley B Lines by Ultrasound and Ejection Fraction (%) Obtained by the Cardiologist With Echocardiography</title>
        <description>Assessing the relationship between number of Kerley B lines by ultrasound and ejection fraction (%) obtained by the cardiologist with echocardiography</description>
        <time_frame>4 months</time_frame>
        <population>PD patients (n=21)</population>
        <group_list>
          <group group_id="O1">
            <title>PD Patients</title>
            <description>PD patients (n=21)</description>
          </group>
        </group_list>
        <measure>
          <title>Association Between Number of Kerley B Lines by Ultrasound and Ejection Fraction (%) Obtained by the Cardiologist With Echocardiography</title>
          <description>Assessing the relationship between number of Kerley B lines by ultrasound and ejection fraction (%) obtained by the cardiologist with echocardiography</description>
          <population>PD patients (n=21)</population>
          <units>percentage of ejection fraction</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>B Lines ≤ 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61" lower_limit="49.7" upper_limit="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B lines &gt; 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" lower_limit="60" upper_limit="62.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle End Diastolic Volume (ml) Obtained by the Cardiologist With Echocardiography</title>
        <description>Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle end diastolic volume (ml) obtained by the cardiologist with echocardiography</description>
        <time_frame>4 months</time_frame>
        <population>PD patients (n=21)</population>
        <group_list>
          <group group_id="O1">
            <title>PD Patients</title>
            <description>PD patients (n=21)</description>
          </group>
        </group_list>
        <measure>
          <title>Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle End Diastolic Volume (ml) Obtained by the Cardiologist With Echocardiography</title>
          <description>Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle end diastolic volume (ml) obtained by the cardiologist with echocardiography</description>
          <population>PD patients (n=21)</population>
          <units>ml</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>B Lines ≤ 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="76.7" upper_limit="128.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B lines &gt; 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94" lower_limit="87.5" upper_limit="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Association Between Number of Kerley B Lines by Ultrasound and Left Atrial Volume (ml) Obtained by the Cardiologist With Echocardiography</title>
        <description>Assessing the relationship between number of Kerley B lines by ultrasound and left atrial volume (ml) obtained by the cardiologist with echocardiography</description>
        <time_frame>4 months</time_frame>
        <population>PD patients (n=21)</population>
        <group_list>
          <group group_id="O1">
            <title>PD Patients</title>
            <description>PD patients (n=21)</description>
          </group>
        </group_list>
        <measure>
          <title>Association Between Number of Kerley B Lines by Ultrasound and Left Atrial Volume (ml) Obtained by the Cardiologist With Echocardiography</title>
          <description>Assessing the relationship between number of Kerley B lines by ultrasound and left atrial volume (ml) obtained by the cardiologist with echocardiography</description>
          <population>PD patients (n=21)</population>
          <units>ml</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>B Lines ≤ 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36" lower_limit="31" upper_limit="44.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B lines &lt; 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37" lower_limit="26" upper_limit="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle Mass Index (g/m2) Obtained by the Cardiologist With Echocardiography</title>
        <description>Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle mass index (g/m2) obtained by the cardiologist with echocardiography</description>
        <time_frame>4 months</time_frame>
        <population>PD patients (n=21)</population>
        <group_list>
          <group group_id="O1">
            <title>PD Patients</title>
            <description>PD patients (n=21)</description>
          </group>
        </group_list>
        <measure>
          <title>Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle Mass Index (g/m2) Obtained by the Cardiologist With Echocardiography</title>
          <description>Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle mass index (g/m2) obtained by the cardiologist with echocardiography</description>
          <population>PD patients (n=21)</population>
          <units>g/m2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>B Lines ≤ 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.5" lower_limit="70.2" upper_limit="129.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B lines &gt; 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75" lower_limit="69.5" upper_limit="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle Filling Velocity (cm/Sec) Obtained by the Cardiologist With Echocardiography</title>
        <description>Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle filling velocity (cm/sec) obtained by the cardiologist with echocardiography</description>
        <time_frame>4 months</time_frame>
        <population>PD patients (n=21)</population>
        <group_list>
          <group group_id="O1">
            <title>PD Patients</title>
            <description>PD patients (n=21)</description>
          </group>
        </group_list>
        <measure>
          <title>Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle Filling Velocity (cm/Sec) Obtained by the Cardiologist With Echocardiography</title>
          <description>Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle filling velocity (cm/sec) obtained by the cardiologist with echocardiography</description>
          <population>PD patients (n=21)</population>
          <units>cm/sec</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>B Lines ≤ 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.5" lower_limit="56.7" upper_limit="86.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B lines &gt; 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74" lower_limit="65" upper_limit="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Association Between Number of Kerley B Lines by Ultrasound and Early Mitral Inflow Velocity and Mitral Annular Early Diastolic Velocity (E/E') Obtained by the Cardiologist With Echocardiography</title>
        <description>Assessing the relationship between number of Kerley B lines by ultrasound and early mitral inflow velocity and mitral annular early diastolic velocity (E/E') obtained by the cardiologist with echocardiography</description>
        <time_frame>4 months</time_frame>
        <population>PD patients (n=21)</population>
        <group_list>
          <group group_id="O1">
            <title>PD Patients</title>
            <description>PD patients (n=21)</description>
          </group>
        </group_list>
        <measure>
          <title>Association Between Number of Kerley B Lines by Ultrasound and Early Mitral Inflow Velocity and Mitral Annular Early Diastolic Velocity (E/E') Obtained by the Cardiologist With Echocardiography</title>
          <description>Assessing the relationship between number of Kerley B lines by ultrasound and early mitral inflow velocity and mitral annular early diastolic velocity (E/E') obtained by the cardiologist with echocardiography</description>
          <population>PD patients (n=21)</population>
          <units>rate</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>B Lines ≤ 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6" lower_limit="9.8" upper_limit="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B lines &gt; 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7" lower_limit="9.9" upper_limit="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Association Between Number of Kerley B Lines by Ultrasound and Pulmonary Artery Systolic Pressure (mmHg) Obtained by the Cardiologist With Echocardiography</title>
        <description>Assessing the relationship between number of Kerley B lines by ultrasound and pulmonary artery systolic pressure (mmHg) obtained by the cardiologist with echocardiography</description>
        <time_frame>4 months</time_frame>
        <population>PD patients (n=21)</population>
        <group_list>
          <group group_id="O1">
            <title>PD Patients</title>
            <description>PD patients (n=21)</description>
          </group>
        </group_list>
        <measure>
          <title>Association Between Number of Kerley B Lines by Ultrasound and Pulmonary Artery Systolic Pressure (mmHg) Obtained by the Cardiologist With Echocardiography</title>
          <description>Assessing the relationship between number of Kerley B lines by ultrasound and pulmonary artery systolic pressure (mmHg) obtained by the cardiologist with echocardiography</description>
          <population>PD patients (n=21)</population>
          <units>mmHg</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>B Lines ≤ 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24" lower_limit="20" upper_limit="33.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B lines &gt; 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24" lower_limit="19" upper_limit="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Association Between Number of Kerley B Lines by Ultrasound and Bioimpedance Analysis [Assessed With the Body Composition Monitor; Normovolemic if Their Result Between -1,1 lt and 1,1 lt)</title>
        <description>Assessing the relationship between number of Kerley B lines by ultrasound and bioimpedance analysis [assessed with the body composition monitor; normovolemic if their result between -1,1 lt and 1,1 lt)</description>
        <time_frame>4 months</time_frame>
        <population>PD patients (n=21)</population>
        <group_list>
          <group group_id="O1">
            <title>PD Patients</title>
            <description>PD patients (n=21)</description>
          </group>
        </group_list>
        <measure>
          <title>Association Between Number of Kerley B Lines by Ultrasound and Bioimpedance Analysis [Assessed With the Body Composition Monitor; Normovolemic if Their Result Between -1,1 lt and 1,1 lt)</title>
          <description>Assessing the relationship between number of Kerley B lines by ultrasound and bioimpedance analysis [assessed with the body composition monitor; normovolemic if their result between -1,1 lt and 1,1 lt)</description>
          <population>PD patients (n=21)</population>
          <units>liter</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>B Lines ≤ 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" lower_limit="0.007" upper_limit="2.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B lines &gt; 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" lower_limit="0.1" upper_limit="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Association Between Number of Kerley B Lines by Ultrasound and NT-proBNP Level (pg/ml) by Elecsys proBNP Immunoassay</title>
        <description>Assessing the relationship between number of Kerley B lines by ultrasound and NT-proBNP level (pg/ml) by Elecsys proBNP Immunoassay</description>
        <time_frame>4 months</time_frame>
        <population>PD patients</population>
        <group_list>
          <group group_id="O1">
            <title>PD Patients</title>
            <description>PD patients (n=21)</description>
          </group>
        </group_list>
        <measure>
          <title>Association Between Number of Kerley B Lines by Ultrasound and NT-proBNP Level (pg/ml) by Elecsys proBNP Immunoassay</title>
          <description>Assessing the relationship between number of Kerley B lines by ultrasound and NT-proBNP level (pg/ml) by Elecsys proBNP Immunoassay</description>
          <population>PD patients</population>
          <units>pg/ml</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>B Lines ≤ 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3024" lower_limit="568" upper_limit="9397"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B lines &gt; 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2217" lower_limit="885" upper_limit="3959"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 months</time_frame>
      <desc>Lung ultrasound is a non-invasive technique, we did not expect any side-effect. And we did not encounter.</desc>
      <group_list>
        <group group_id="E1">
          <title>PD Patients</title>
          <description>21 PD patients treated in out unit were enrolled.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The main limitation of this study is a limited number of patients.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Mustafa Sevinc</name_or_title>
      <organization>Sisli Hamidiye Etfal Training and Research Hospital</organization>
      <phone>00905309291239</phone>
      <email>musevinc@hotmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03801044
org study id: 1908
nct id: NCT03801044
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Although many alternative methods are present, maintaining ideal volume status in peritoneal
      dialysis (PD) patients still rely on clinical evaluation due to lack of an evidence based
      method. Lung ultrasound (LUS) is a new method for evaluation of hidden congestion in this
      group. LUS findings and its relationship with other volumetric methods are investigated in
      this study. LUS was performed to all peritoneal dialysis patients and compared with symptoms
      of hypervolemia, physical examination, vascular endothelial growth factor-C (VEGF-C) and
      N-terminal pro-brain natriuretic peptide levels, chest radiography, echocardiography,
      bioelectrical impedance analysis.
Maintaining volume control is crucial in all renal replacement therapy modalities. Fluid
      overload is associated with increased mortality both in hemodialysis patients and peritoneal
      dialysis (PD) patients although peritoneal dialysis has the advantage of better preservation
      of residual renal function compared to hemodialysis. Many methods have been used to fine tune
      the volume status of patients including physical examination, chest radiography, blood
      pressure, laboratory parameters, echocardiography, bioelectrical impedance analysis (BIA),
      ultrasound for lung.

      Symptoms of hypervolemia are mainly paroxysmal nocturnal dyspnea, orthopnea, edema, dyspnea
      on exertion. On physical examination, hypertension or hypotension, third heart sound, jugular
      venous distension, rales, edema can be seen. Pulmonary venous congestion, cardiomegaly,
      interstitial edema, alveolar edema, pleural effusion can be seen on chest radiographies.

      Level of N-terminal pro-brain natriuretic peptide (NT-proBNP) increases upon stretching of
      cardiac myocytes. This is accepted as a reflection of volume status. There are a few studies
      in which NT-proBNP was found as a useful marker for hypervolemia both in hemodialysis and
      peritoneal dialysis population.

      Vascular endothelial growth factor-C (VEGF-C) is an osmosensitive gene product secreted by
      macrophages through activation of tonicity-responsive enhancer binding protein found in
      mononuclear phagocyte system cells infiltrating the interstitium. The result is hypertonic
      sodium accumulation in the skin which is accepted as a buffer mechanism maintaining blood
      pressure homeostasis. Serum VEGF-C levels had been found as a promising marker of
      hypervolemia in a hemodialysis patient cohort by a recent study.

      Echocardiography has been used extensively in dialysis patients in which a number of
      parameters have been measured. Bioelectrical impedance analysis (BIA) is another non-invasive
      bedside method for the evaluation of volume status.

      Lung ultrasound (LUS) is a technique that has become popular in nephrology recently. "B
      lines" or "lung comets" are the reverberation artifacts arising from the pleural line. They
      are produced due to thickened subpleural interlobular septa by edema.

      The gold standard for volume assessment is isotope dilution and neutron activation analysis
      methods which are only limited to research activities. The best widely accepted,
      non-invasive, practical, easy to access method has not been decided yet. Moreover evidence is
      quite scarce for the peritoneal dialysis than hemodialysis or normal renal functioning group.
      Lung ultrasound is the most recent promising method for volume control.

      The investigators aimed to define lung ultrasound findings in our peritoneal dialysis cohort
      and its relation with other volumetric parameters.
observational model: Cohort
time perspective: Cross-Sectional
measure: Association Between Number of Kerley B Lines by Ultrasound and Serum VEGF-C Level (pg/ml) by Enzyme-linked Immunosorbent Assay
time frame: 4 months
description: Assessing the relationship between number of Kerley B lines by ultrasound and serum VEGF-C level (pg/ml) by enzyme-linked immunosorbent assay
measure: Association Between Number of Kerley B Lines by Ultrasound and Dyspnea by Questionnaire
time frame: 4 months
description: Assessing the relationship between number of Kerley B lines by ultrasound and dyspnea by questionnaire
measure: Association Between Number of Kerley B Lines by Ultrasound and Class of New York Heart Association Classification
time frame: 4 months
description: Assessing the relationship between number of Kerley B lines by ultrasound and class of New York Heart Association Classification
measure: Association Between Number of Kerley B Lines by Ultrasound and Presence of Third Sound/Pretibial Edema by Auscultation/Edema by Physical Examination
time frame: 4 months
description: Assessing the relationship between number of Kerley B lines by ultrasound and presence of third sound (S3) by auscultation/edema by physical examination
measure: Association Between Number of Kerley B Lines by Ultrasound Left Ventricle End Diastolic Diameter (mm) Obtained by the Cardiologist With Echocardiography
time frame: 4 months
description: Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle end diastolic diameter (mm) obtained by the cardiologist with echocardiography
measure: Association Between Number of Kerley B Lines by Ultrasound Interventricular Septum Thickness (mm) Obtained by the Cardiologist With Echocardiography
time frame: 4 months
description: Assessing the relationship between number of Kerley B by ultrasound and interventricular septum thickness (mm) (mm) obtained by the cardiologist with echocardiography
measure: Association Between Number of Kerley B by Ultrasound and Posterior Wall Thickness (mm) Obtained by the Cardiologist With Echocardiography
time frame: 4 months
description: Assessing the relationship between number of Kerley B by ultrasound and posterior wall thickness (mm) obtained by the cardiologist with echocardiography
measure: Association Between Number of Kerley B Lines by Ultrasound and Ejection Fraction (%) Obtained by the Cardiologist With Echocardiography
time frame: 4 months
description: Assessing the relationship between number of Kerley B lines by ultrasound and ejection fraction (%) obtained by the cardiologist with echocardiography
measure: Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle End Diastolic Volume (ml) Obtained by the Cardiologist With Echocardiography
time frame: 4 months
description: Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle end diastolic volume (ml) obtained by the cardiologist with echocardiography
measure: Association Between Number of Kerley B Lines by Ultrasound and Left Atrial Volume (ml) Obtained by the Cardiologist With Echocardiography
time frame: 4 months
description: Assessing the relationship between number of Kerley B lines by ultrasound and left atrial volume (ml) obtained by the cardiologist with echocardiography
measure: Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle Mass Index (g/m2) Obtained by the Cardiologist With Echocardiography
time frame: 4 months
description: Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle mass index (g/m2) obtained by the cardiologist with echocardiography
measure: Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle Filling Velocity (cm/Sec) Obtained by the Cardiologist With Echocardiography
time frame: 4 months
description: Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle filling velocity (cm/sec) obtained by the cardiologist with echocardiography
measure: Association Between Number of Kerley B Lines by Ultrasound and Early Mitral Inflow Velocity and Mitral Annular Early Diastolic Velocity (E/E') Obtained by the Cardiologist With Echocardiography
time frame: 4 months
description: Assessing the relationship between number of Kerley B lines by ultrasound and early mitral inflow velocity and mitral annular early diastolic velocity (E/E') obtained by the cardiologist with echocardiography
measure: Association Between Number of Kerley B Lines by Ultrasound and Pulmonary Artery Systolic Pressure (mmHg) Obtained by the Cardiologist With Echocardiography
time frame: 4 months
description: Assessing the relationship between number of Kerley B lines by ultrasound and pulmonary artery systolic pressure (mmHg) obtained by the cardiologist with echocardiography
measure: Association Between Number of Kerley B Lines by Ultrasound and Bioimpedance Analysis [Assessed With the Body Composition Monitor; Normovolemic if Their Result Between -1,1 lt and 1,1 lt)
time frame: 4 months
description: Assessing the relationship between number of Kerley B lines by ultrasound and bioimpedance analysis [assessed with the body composition monitor; normovolemic if their result between -1,1 lt and 1,1 lt)
measure: Association Between Number of Kerley B Lines by Ultrasound and NT-proBNP Level (pg/ml) by Elecsys proBNP Immunoassay
time frame: 4 months
description: Assessing the relationship between number of Kerley B lines by ultrasound and NT-proBNP level (pg/ml) by Elecsys proBNP Immunoassay
arm group label: PD patients
description: All PD patients treated in out unit were enrolled.
intervention type: Diagnostic Test
intervention name: NT-BNP, VEGF
description: VEGF-C levels were measured in the serum samples. R&D Systems kit (Minneapolis, MN) (Catalog Number DVEC00) was used for the assays according to the user instructions. NT-proBNP was measured on the Elecsys 2010 analyzer (Elecsys proBNP Immunoassay; Roche Diagnostics).
arm group label: PD patients
intervention type: Diagnostic Test
intervention name: Echocardiography
description: Transthoracic echocardiography was performed by the same cardiologist blinded to all other parameters. It was done while abdomen was empty. LV end diastolic diameter (mm), interventricular septum thickness (mm), posterior wall thickness (mm), ejection fraction (%), left ventricle end diastolic volume (ml), left atrial volume (ml), left ventricle mass index (LVMI) (g/m2), left ventricle filling velocity(cm/sec), E/E' ratio, pulmonary artery systolic pressure (mm Hg) were the parameters taken by echocardiography
arm group label: PD patients
intervention type: Radiation
intervention name: Chest Radiography
description: All radiographies were taken when the patient was standing erect position during deep inhalation. They were reported by an expert radiologist blinded to clinical data. Films taken at supine position or during exhalation were excluded. Chest radiographies were classified into 3 stages to reflect degree of hypervolemia. Stage 1 was redistribution defined as increased artery-to-bronchus ratio in the upper and middle lobes. Stage 2 was interstitial edema evident by Kerley B lines and peribronchial cuffing. Stage 3 was alveolar edema phase perihilar consolidation and air bronchograms, pleural fluid, increased width of the vascular pedicle, enlarged cardiac silhouette.
arm group label: PD patients
intervention type: Diagnostic Test
intervention name: Lung Ultrasound
description: It was performed by 28 area method which contains ultrasound examination from second to fifth intercostals spaces at parasternal region, midclavicular line, anterior and mid axillary lines. Lung ultrasound had been done by same radiologist who was an expertise in ultrasonography blinded to all other parameters. It was performed by 1,6 megaHertz convex probe when patient lying at the supine position.
arm group label: PD patients
intervention type: Diagnostic Test
intervention name: Bioelectrical Impedence Analysis
description: The Body Composition Monitor (BCM) (type 0BJA1394, Fresenius Medical Care AG & Co. KGaA, D-61343 Bad Homburg) was used for assessment of hydration status in patients. Peritoneal cavities were free of intraperitoneal fluid during measurement. Patients were accepted as normovolemic if their result were between -1.1lt and 1.1 lt.
arm group label: PD patients
Serum samples for levels of vascular endothelial growth factor and N-terminal pro-brain
      natriuretic peptide
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Sisli Hamidiye Etfal Training and Research Hospital
investigator full name: Nuri Baris Hasbal
investigator title: MD
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The main limitation of this study is a limited number of patients.
point of contact: 