<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/NCT03274518</url>
  </required_header>
  <id_info>
    <org_study_id>16928</org_study_id>
    <nct_id>NCT03274518</nct_id>
  </id_info>
  <brief_title>Expanded Hemodialysis Versus Online Hemodiafiltration</brief_title>
  <official_title>Expanded Hemodialysis Versus Online Hemodiafiltration: a Pilot Study on Intradialytic Hemodynamics and Fluid Status</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</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>
      Conventional hemodialysis (HD) is essential for the treatment of end-stage renal disease&#xD;
      (ESRD) patients, by reducing serum concentration of uremic toxins and correcting fluid&#xD;
      overload.&#xD;
&#xD;
      Nevertheless, HD removes almost exclusively low-range uremic toxins. Therefore, medium-range&#xD;
      molecules, such as beta-2-microglobulin might accumulate in tissues, leading to many clinical&#xD;
      complications, such as neuropathies, tendinopathies, anemia, bone mineral disease and reduced&#xD;
      growth in children.&#xD;
&#xD;
      Convective methods might reduce incidence of these complications, by removing molecules of&#xD;
      medium-range molecular weight. Online hemodiafiltration (olHDF) is the most extensively used&#xD;
      method in this regard. Nevertheless, there are some barriers to the wider introduction of&#xD;
      this method in clinical practice, since specific machines are needed for this procedure, the&#xD;
      costs with dialysis lines are higher and water consumption increases. More recently, the&#xD;
      development of new membranes for hemodialysis allowed removal of medium- and high-range&#xD;
      uremic toxins, with albumin retention. Thus, they allow removal of a broad range of uremic&#xD;
      toxins, without changing dialysis machine or increasing water consumption. Such therapy is&#xD;
      known as expanded hemodialysis (HDx).&#xD;
&#xD;
      The aim of this present study is to compare the extraction of middle-size molecules, the&#xD;
      hemodynamic behavior, fluid and nutritional status of patients submitted to olHDF or HDx, in&#xD;
      a crossover study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis&#xD;
&#xD;
      Our hypothesis is that HDx is noninferior to olHDF in the following parameters:&#xD;
&#xD;
        -  Hemodynamic stability&#xD;
&#xD;
        -  Nutritional and fluid status&#xD;
&#xD;
        -  Removal of beta-2 microglobulin&#xD;
&#xD;
      Objectives To evaluate each patient, through a prospective, randomized and cross-over study,&#xD;
      the intradialytic hemodynamic behavior, fluid and nutritional status assessed by electrical&#xD;
      bioimpedance and B2M removal in two dialytic modalities: HDFol versus HDx.&#xD;
&#xD;
      Concise methods&#xD;
&#xD;
        1. Clinical and laboratorial data Clinical data will be collected from the institution's&#xD;
           chart, recorded and filled with all necessary precautions to keep confidentiality of&#xD;
           patient's information. They are: baseline renal disease, age, history of smoking,&#xD;
           sedentary lifestyle, presence of comorbidities such as hypertension and diabetes&#xD;
           mellitus, family history of cardiovascular disease, history of coronary and&#xD;
           cerebrovascular disease and medications.&#xD;
&#xD;
           Laboratory tests used to determine the biochemical, hematological and bone mineral&#xD;
           profile characteristics will be obtained from routinely collected exams. Such exams are&#xD;
           processed by the Central Laboratory of Hospital das Clínicas / FMUSP.&#xD;
&#xD;
        2. Dialysis All dialysis procedures will be performed by the Dialog+ Admea™ machine (BBraun&#xD;
           Melsungen AG, Germany).&#xD;
&#xD;
           The olHDF will be prescribed as follows: blood flow 350 - 400 ml/min, dialysate flow 800&#xD;
           ml/min, post-dilution flow (90-100 ml/min), with high-flux Xevonta™ (BBraun Melsungen&#xD;
           AG, Germany) or CAHP/DICE™ (Baxter Healthcare Corporation, Germany) dialyzers, with&#xD;
           surface area of 1.7-2.4 m². The duration of each session will be from 3,5h to 4h,&#xD;
           depending on current dialysis prescription. Total substitution volume will be higher&#xD;
           than 20 L per session.&#xD;
&#xD;
           HDx will follow the same prescription of olHDF, regarding blood and dialysate flows and&#xD;
           dialysis duration. There will be no substitution volume. Theranova™ dialyzers (Baxter&#xD;
           Healthcare Corporation, Germany) will be used for each session.&#xD;
&#xD;
           Before initiating protocol and during the washout period, patients will be submitted to&#xD;
           high-flux HD, which is the standard treatment in our service.&#xD;
&#xD;
        3. Hemodynamic monitoring Cardiac output index (CI), stroke volume (SV - integrated mean of&#xD;
           the flow waveform between the current upstroke and the dichotic notch), peripheral&#xD;
           arterial resistance (PAR - ratio of mean arterial pressure to stroke volume multiplied&#xD;
           by heart rate) and blood pressure (BP) will be accessed by finger beat to-beat monitor&#xD;
           Finometer™ (Finapress Medical Systems BV, Arnhem, The Netherlands), within 15 minutes&#xD;
           after starting olHDF or HDx sessions (predialysis) and again, 15 minutes before its end&#xD;
           (post-dialysis).&#xD;
&#xD;
        4. Bioelectrical impedance Segmental tetrapolar bioelectrical impedance (BIS) will be&#xD;
           performed in all patients while recumbent, before starting study protocol and before&#xD;
           each phase of the study (HDx or olHDF), by the multifrequency InBody™ S10 (Biospace Co.,&#xD;
           Ltd., Korea) device. It allows assessment of the following parameters regarding body&#xD;
           fluids: total body water, total extracellular body water, lower limbs total water&#xD;
           content, lower limbs extracellular water content. Additionally, α-angle, which is a&#xD;
           marker of cellular integrity and nutritional status, will be noted.&#xD;
&#xD;
        5. Blood and Effluent samples Blood samples will be collected pre-session, mid-session and&#xD;
           post-dialysis sessions, both in the first and last dialysis sessions of each of the&#xD;
           periods studied (HDFol or HDx). Pre-session blood samples will be collected immediately&#xD;
           after arteriovenous fistula puncture and the middle and post-session samples will be&#xD;
           collected from the arterial line, 2 minutes after reduction of blood flow to 50 ml/min&#xD;
           and suspension of dialysate flow and/ or replacement.&#xD;
&#xD;
      In addition, partial and homogeneous collection of the effluent will be performed by a&#xD;
      drainage hose, with an infusion pump operating continuously at a rate of 1l/h. The whole&#xD;
      effluent of dialysis session will be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2017</start_date>
  <completion_date type="Actual">March 11, 2019</completion_date>
  <primary_completion_date type="Actual">October 18, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Investigator who collects laboratorial, hemodynamics and bioimpedance data will be blinded for intervention (online hemodiafiltration or expanded hemodialysis)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Medium Molecule Clearance</measure>
    <time_frame>One month after starting protocol</time_frame>
    <description>Beta-2-Microglobulin clearance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medium Molecule Removal</measure>
    <time_frame>One month after starting protocol</time_frame>
    <description>Beta-2-Microglobulin extraction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intradialytic Hemodynamics</measure>
    <time_frame>Cardiac output (liters per minute) one month after starting protocol</time_frame>
    <description>noninvasive cardiac output assessment</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Fluid Status</measure>
    <time_frame>One month after starting protocol</time_frame>
    <description>noninvasive assessment of extracellular and total body water</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Dialysis Related Complication</condition>
  <condition>Dialysis Hypotension</condition>
  <condition>Hemodialysis-Induced Symptom</condition>
  <arm_group>
    <arm_group_label>Online Hemodiafiltration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The olHDF technique combines diffusion with high convection rates in which the dialysis fluid, free of toxins and pyrogens, is used to prepare the replacement fluid.&#xD;
The online module of dialysis machine prepares the replacement fluid by a cold sterilization process. There is a cross-flow water preparation, in order to avoid the accumulation of possible contaminants. The addition of bicarbonate and acid solutions to water follows the process. Next, the ready-for-infusion dialysis solution is passed through another ultrafilter prior to being infused into patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expanded Hemodialysis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>More recently, membranes with high cutoff values, but with tight pore size distribution have been developed. The main concept is to keep both cutoff and retention onset values close to each other, but with a cutoff value lower than of albumin. This should allow removal of middle-to-high weight range uremic toxins, with very low albumin leak. Thus, these membranes, denominated high retention onset (HRO) membranes, allow performing both diffusive and convective processes in a conventional hemodialysis machine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Expanded Hemodialysis</intervention_name>
    <description>Intervention: Conversion from conventional HD to expanded hemodialysis por 1 month.&#xD;
High cutoff with high retention onset dialyzers allow clearance of middle molecules, without reducing significantly serum concentration of albumin. It allows higher convective clearance in comparison to conventional hemodialysis, but it is unknown if such clearance is similar to online hemodiafiltration. Therefore, the aim of the present intervention is to compare this dialyzer with online hemodiafiltration</description>
    <arm_group_label>Expanded Hemodialysis</arm_group_label>
    <other_name>Theranova Dialyzer</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Online Hemodiafiltration</intervention_name>
    <description>Intervention: Conversion from conventional HD to online Hemodiafiltration por 1 month.&#xD;
Online hemodiafiltration has been associated with lower incidence of intradialytic hypotension in comparison to conventional hemodialysis.</description>
    <arm_group_label>Online Hemodiafiltration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients who are on maintenance hemodialysis at Hospital das Clínicas and agree&#xD;
             to participate in the study by signing the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who cannot understand or who refuse to sign the informed consent form;&#xD;
             Patients who are currently on daily hemodialysis or online hemodiafiltration.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruno C Silva, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Renal Division, Unversity of São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital das Clínicas</name>
      <address>
        <city>São Paulo</city>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <results_reference>
    <citation>Karohl C, de Paiva Paschoal J, de Castro MC, Elias RM, Abensur H, Romao JE Jr, Passlick-Deetjen J, Jorgetti V, Moyses RM. Effects of bone remodelling on calcium mass transfer during haemodialysis. Nephrol Dial Transplant. 2010 Apr;25(4):1244-51. doi: 10.1093/ndt/gfp597. Epub 2010 Jan 29.</citation>
    <PMID>20118484</PMID>
  </results_reference>
  <results_reference>
    <citation>Cheng YL, Shek CC, Wong FK, Choi KS, Chau KF, Ing TS, Li CS. Determination of the solute removal index for urea by using a partial spent dialysate collection method. Am J Kidney Dis. 1998 Jun;31(6):986-90. doi: 10.1053/ajkd.1998.v31.pm9631843. Erratum In: Am J Kidney Dis 1998 Oct;32(4):704.</citation>
    <PMID>9631843</PMID>
  </results_reference>
  <results_reference>
    <citation>Alvares VRC, Ramos CD, Pereira BJ, Pinto AL, Moyses RMA, Gualano B, Elias RM. Pneumatic Compression, But Not Exercise, Can Avoid Intradialytic Hypotension: A Randomized Trial. Am J Nephrol. 2017;45(5):409-416. doi: 10.1159/000471513. Epub 2017 Apr 14.</citation>
    <PMID>28407637</PMID>
  </results_reference>
  <results_reference>
    <citation>Cheng YL, Shek CC, Wong AK, Wong FK, Chau KF, Li CS. A partial dialysate collection method. Int J Artif Organs. 1997 Jan;20(1):14-7.</citation>
    <PMID>9062826</PMID>
  </results_reference>
  <results_reference>
    <citation>Argiles A, Ficheux A, Thomas M, Bosc JY, Kerr PG, Lorho R, Flavier JL, Stec F, Adele C, Leblanc M, Garred LJ, Canaud B, Mion H, Mion CM. Precise quantification of dialysis using continuous sampling of spent dialysate and total dialysate volume measurement. Kidney Int. 1997 Aug;52(2):530-7. doi: 10.1038/ki.1997.364.</citation>
    <PMID>9264013</PMID>
  </results_reference>
  <results_reference>
    <citation>Oliveira CM, Kubrusly M, Mota RS, Silva CA, Choukroun G, Oliveira VN. The phase angle and mass body cell as markers of nutritional status in hemodialysis patients. J Ren Nutr. 2010 Sep;20(5):314-20. doi: 10.1053/j.jrn.2010.01.008. Epub 2010 Mar 19.</citation>
    <PMID>20303790</PMID>
  </results_reference>
  <results_reference>
    <citation>Silva BC, Freitas GR, Silva VB, Abensur H, Luders C, Pereira BJ, de Oliveira RB, Castro MC, Moyses RM, Elias RM. Hemodynamic behavior during hemodialysis: effects of dialysate concentrations of bicarbonate and potassium. Kidney Blood Press Res. 2014;39(5):490-6. doi: 10.1159/000368459. Epub 2014 Nov 23.</citation>
    <PMID>25532082</PMID>
  </results_reference>
  <results_reference>
    <citation>Silva BC, Moyses RM, Silva VB, Freitas GR, Elias RM. Parathyroidectomized patients have impaired capacity of peripheral vascular constriction during hemodialysis. Hemodial Int. 2016 Jan;20(1):50-5. doi: 10.1111/hdi.12309. Epub 2015 Apr 28.</citation>
    <PMID>25923250</PMID>
  </results_reference>
  <results_reference>
    <citation>Jimenez ZN, Silva BC, Reis LD, Castro MC, Ramos CD, Costa-Hong V, Bortolotto LA, Consolim-Colombo F, Dominguez WV, Oliveira IB, Moyses RM, Elias RM. High Dialysate Calcium Concentration May Cause More Sympathetic Stimulus During Hemodialysis. Kidney Blood Press Res. 2016;41(6):978-985. doi: 10.1159/000452601. Epub 2016 Dec 16.</citation>
    <PMID>27978518</PMID>
  </results_reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <results_first_submitted>March 12, 2019</results_first_submitted>
  <results_first_submitted_qc>September 27, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 30, 2019</results_first_posted>
  <last_update_submitted>September 27, 2019</last_update_submitted>
  <last_update_submitted_qc>September 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Bruno Caldin da Silva</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Hemodialysis</keyword>
  <keyword>Hemodiafiltration</keyword>
  <keyword>fluid status</keyword>
  <keyword>hemodynamics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <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>September 27, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03274518/Prot_SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03274518/ICF_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Online Hemodiafiltration</title>
          <description>Arm description: Online Hemodiafiltration first, then expanded hemodialysis.&#xD;
First, patients changed fom conventional HD to online hemodiafiltration for 1 month.&#xD;
Then, patients returned to conventional HD for 2 weeks (washout period). Then, patients underwent the second intervention (expanded hemodialysis) for 1 month, in a cross-over design.</description>
        </group>
        <group group_id="P2">
          <title>Expanded Hemodialysis</title>
          <description>Arm description: expanded hemodialysis first, then online hemodiafiltration.&#xD;
Intervention: Conversion from conventional HD to expanded hemodialysis for 1 month.&#xD;
Then, patients returned to conventional HD for 2 weeks (washout period). Then, they underwent the second intervention (online hemodiafiltration), for 1 month, in a cross-over design.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8">First intervention: expanded hemodialysis, for 30 days.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8">Patients returned from expanded hemodialysis to conventional hemodialysis for 15 days.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8">Second intervention: patients from this group underwent online hemodiafiltration for 30 days.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Online Hemodiafiltration</title>
          <description>Patients were included in this study group per sequence:&#xD;
Online hemodiafiltration (olHDF) first for 1 month, then expanded hemodialysis (HDx) for 1 month.&#xD;
Baseline characteristics assessed:&#xD;
Age&#xD;
Gender&#xD;
Ethnicity&#xD;
Region of Enrollment&#xD;
Serum Beta-2 Microglobulin</description>
        </group>
        <group group_id="B2">
          <title>Expanded Hemodialysis</title>
          <description>Patients were included in this study group per sequence:&#xD;
Expanded hemodialysis (HDx) first for 1 month, then online hemodiafiltration (olHDF) for 1 month.&#xD;
Baseline characteristics assessed:&#xD;
Age&#xD;
Gender&#xD;
Ethnicity&#xD;
Region of Enrollment&#xD;
Serum Beta-2 Microglobulin</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="16"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.5" lower_limit="28.7" upper_limit="43.5"/>
                    <measurement group_id="B2" value="46" lower_limit="28.7" upper_limit="59.5"/>
                    <measurement group_id="B3" value="39.5" lower_limit="28.7" upper_limit="52.2"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Brazil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum Beta-2 Microglobulin</title>
          <units>mcg/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.2" spread="6.9"/>
                    <measurement group_id="B2" value="27.8" spread="5.5"/>
                    <measurement group_id="B3" value="25.2" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Medium Molecule Clearance</title>
        <description>Beta-2-Microglobulin clearance</description>
        <time_frame>One month after starting protocol</time_frame>
        <population>Beta-2 Microglobulin clearance (ml/min)</population>
        <group_list>
          <group group_id="O1">
            <title>Online Hemodiafiltration</title>
            <description>The olHDF technique combines diffusion with high convection rates in which the dialysis fluid, free of toxins and pyrogens, is used to prepare the replacement fluid.&#xD;
The online module of dialysis machine prepares the replacement fluid by a cold sterilization process. There is a cross-flow water preparation, in order to avoid the accumulation of possible contaminants. The addition of bicarbonate and acid solutions to water follows the process. Next, the ready-for-infusion dialysis solution is passed through another ultrafilter prior to being infused into patients.</description>
          </group>
          <group group_id="O2">
            <title>Expanded Hemodialysis</title>
            <description>High cutoff with high retention onset dialyzers allow clearance of middle molecules, without reducing significantly serum concentration of albumin.</description>
          </group>
        </group_list>
        <measure>
          <title>Medium Molecule Clearance</title>
          <description>Beta-2-Microglobulin clearance</description>
          <population>Beta-2 Microglobulin clearance (ml/min)</population>
          <units>ml/min</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="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53" lower_limit="41.8" upper_limit="63.7"/>
                    <measurement group_id="O2" value="59.5" lower_limit="50.5" upper_limit="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority margin was defined as difference within 20% in comparison to reference method (olHDF)</non_inferiority_desc>
            <p_value>0.4534</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Medium Molecule Removal</title>
        <description>Beta-2-Microglobulin extraction</description>
        <time_frame>One month after starting protocol</time_frame>
        <population>Beta-2-microglobulin mass extraction (mg)</population>
        <group_list>
          <group group_id="O1">
            <title>Online Hemodiafiltration</title>
            <description>The olHDF technique combines diffusion with high convection rates in which the dialysis fluid, free of toxins and pyrogens, is used to prepare the replacement fluid.&#xD;
The online module of dialysis machine prepares the replacement fluid by a cold sterilization process. There is a cross-flow water preparation, in order to avoid the accumulation of possible contaminants. The addition of bicarbonate and acid solutions to water follows the process. Next, the ready-for-infusion dialysis solution is passed through another ultrafilter prior to being infused into patients.</description>
          </group>
          <group group_id="O2">
            <title>Expanded Hemodialysis</title>
            <description>High cutoff with high retention onset dialyzers allow clearance of middle molecules, without reducing significantly serum concentration of albumin.</description>
          </group>
        </group_list>
        <measure>
          <title>Medium Molecule Removal</title>
          <description>Beta-2-Microglobulin extraction</description>
          <population>Beta-2-microglobulin mass extraction (mg)</population>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="198" spread="81"/>
                    <measurement group_id="O2" value="239" spread="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority margin was defined as difference within 20% in comparison to reference method (olHDF)</non_inferiority_desc>
            <p_value>0.1179</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intradialytic Hemodynamics</title>
        <description>noninvasive cardiac output assessment</description>
        <time_frame>Cardiac output (liters per minute) one month after starting protocol</time_frame>
        <population>Intradialytic cardiac output variation (post-pre dialysis), l/min</population>
        <group_list>
          <group group_id="O1">
            <title>Online Hemodiafiltration</title>
            <description>The olHDF technique combines diffusion with high convection rates in which the dialysis fluid, free of toxins and pyrogens, is used to prepare the replacement fluid.&#xD;
The online module of dialysis machine prepares the replacement fluid by a cold sterilization process. There is a cross-flow water preparation, in order to avoid the accumulation of possible contaminants. The addition of bicarbonate and acid solutions to water follows the process. Next, the ready-for-infusion dialysis solution is passed through another ultrafilter prior to being infused into patients.</description>
          </group>
          <group group_id="O2">
            <title>Expanded Hemodialysis</title>
            <description>High cutoff with high retention onset dialyzers allow clearance of middle molecules, without reducing significantly serum concentration of albumin.</description>
          </group>
        </group_list>
        <measure>
          <title>Intradialytic Hemodynamics</title>
          <description>noninvasive cardiac output assessment</description>
          <population>Intradialytic cardiac output variation (post-pre dialysis), l/min</population>
          <units>l/min</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="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" lower_limit="-2.2" upper_limit="-0.3"/>
                    <measurement group_id="O2" value="-1.4" lower_limit="-3" upper_limit="-1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority margin was defined as difference within 20% in comparison to reference method (olHDF)</non_inferiority_desc>
            <p_value>0.3054</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Fluid Status</title>
        <description>noninvasive assessment of extracellular and total body water</description>
        <time_frame>One month after starting protocol</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Online Hemodiafiltration</title>
            <description>The olHDF technique combines diffusion with high convection rates in which the dialysis fluid, free of toxins and pyrogens, is used to prepare the replacement fluid.&#xD;
The online module of dialysis machine prepares the replacement fluid by a cold sterilization process. There is a cross-flow water preparation, in order to avoid the accumulation of possible contaminants. The addition of bicarbonate and acid solutions to water follows the process. Next, the ready-for-infusion dialysis solution is passed through another ultrafilter prior to being infused into patients.</description>
          </group>
          <group group_id="O2">
            <title>Expanded Hemodialysis</title>
            <description>High cutoff with high retention onset dialyzers allow clearance of middle molecules, without reducing significantly serum concentration of albumin.</description>
          </group>
        </group_list>
        <measure>
          <title>Fluid Status</title>
          <description>noninvasive assessment of extracellular and total body water</description>
          <units>liter/liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.39" spread="0.01"/>
                    <measurement group_id="O2" value="0.385" spread="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The lower the ECW/TBW ratio, the lower pre-dialysis excess fluid. A non-inferiority margin was defined as difference within 10% from reference method (olHDF)</non_inferiority_desc>
            <p_value>0.045</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <desc>No adverse events noted</desc>
      <group_list>
        <group group_id="E1">
          <title>Online Hemodiafiltration</title>
          <description>The olHDF technique combines diffusion with high convection rates in which the dialysis fluid, free of toxins and pyrogens, is used to prepare the replacement fluid.&#xD;
The online module of dialysis machine prepares the replacement fluid by a cold sterilization process. There is a cross-flow water preparation, in order to avoid the accumulation of possible contaminants. The addition of bicarbonate and acid solutions to water follows the process. Next, the ready-for-infusion dialysis solution is passed through another ultrafilter prior to being infused into patients.&#xD;
Online Hemodiafiltration: Intervention: Conversion from conventional HD to online Hemodiafiltration por 1 month.&#xD;
Online hemodiafiltration has been associated with lower incidence of intradialytic hypotension in comparison to conventional hemodialysis.</description>
        </group>
        <group group_id="E2">
          <title>Expanded Hemodialysis</title>
          <description>More recently, membranes with high cutoff values, but with tight pore size distribution have been developed. The main concept is to keep both cutoff and retention onset values close to each other, but with a cutoff value lower than of albumin. This should allow removal of middle-to-high weight range uremic toxins, with very low albumin leak. Thus, these membranes, denominated high retention onset (HRO) membranes, allow performing both diffusive and convective processes in a conventional hemodialysis machine. Expanded Hemodialysis: Intervention: Conversion from conventional HD to expanded hemodialysis por 1 month.&#xD;
High cutoff with high retention onset dialyzers allow clearance of middle molecules, without reducing serum concentration of albumin. It allows higher convective clearance in comparison to conventional hemodialysis, but it is unknown if such clearance is similar to online hemodiafiltration. Therefore, the aim of the present intervention is to compare this dialy</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="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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 sample size was small and trial length was relatively short. We did not directly assessed albumin extraction. Besides, the relatively low ultrafiltration coefficient of both dialyzers limited dialysis performance in all treatment groups.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Bruno Caldin da Silva</name_or_title>
      <organization>University of São Paulo</organization>
      <phone>+5511997620521</phone>
      <email>bruno.caldin@hc.fm.usp.br</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/NCT03274518
org study id: 16928
nct id: NCT03274518
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Conventional hemodialysis (HD) is essential for the treatment of end-stage renal disease
      (ESRD) patients, by reducing serum concentration of uremic toxins and correcting fluid
      overload.

      Nevertheless, HD removes almost exclusively low-range uremic toxins. Therefore, medium-range
      molecules, such as beta-2-microglobulin might accumulate in tissues, leading to many clinical
      complications, such as neuropathies, tendinopathies, anemia, bone mineral disease and reduced
      growth in children.

      Convective methods might reduce incidence of these complications, by removing molecules of
      medium-range molecular weight. Online hemodiafiltration (olHDF) is the most extensively used
      method in this regard. Nevertheless, there are some barriers to the wider introduction of
      this method in clinical practice, since specific machines are needed for this procedure, the
      costs with dialysis lines are higher and water consumption increases. More recently, the
      development of new membranes for hemodialysis allowed removal of medium- and high-range
      uremic toxins, with albumin retention. Thus, they allow removal of a broad range of uremic
      toxins, without changing dialysis machine or increasing water consumption. Such therapy is
      known as expanded hemodialysis (HDx).

      The aim of this present study is to compare the extraction of middle-size molecules, the
      hemodynamic behavior, fluid and nutritional status of patients submitted to olHDF or HDx, in
      a crossover study.
Hypothesis

      Our hypothesis is that HDx is noninferior to olHDF in the following parameters:

        -  Hemodynamic stability

        -  Nutritional and fluid status

        -  Removal of beta-2 microglobulin

      Objectives To evaluate each patient, through a prospective, randomized and cross-over study,
      the intradialytic hemodynamic behavior, fluid and nutritional status assessed by electrical
      bioimpedance and B2M removal in two dialytic modalities: HDFol versus HDx.

      Concise methods

        1. Clinical and laboratorial data Clinical data will be collected from the institution's
           chart, recorded and filled with all necessary precautions to keep confidentiality of
           patient's information. They are: baseline renal disease, age, history of smoking,
           sedentary lifestyle, presence of comorbidities such as hypertension and diabetes
           mellitus, family history of cardiovascular disease, history of coronary and
           cerebrovascular disease and medications.

           Laboratory tests used to determine the biochemical, hematological and bone mineral
           profile characteristics will be obtained from routinely collected exams. Such exams are
           processed by the Central Laboratory of Hospital das Clínicas / FMUSP.

        2. Dialysis All dialysis procedures will be performed by the Dialog+ Admea™ machine (BBraun
           Melsungen AG, Germany).

           The olHDF will be prescribed as follows: blood flow 350 - 400 ml/min, dialysate flow 800
           ml/min, post-dilution flow (90-100 ml/min), with high-flux Xevonta™ (BBraun Melsungen
           AG, Germany) or CAHP/DICE™ (Baxter Healthcare Corporation, Germany) dialyzers, with
           surface area of 1.7-2.4 m². The duration of each session will be from 3,5h to 4h,
           depending on current dialysis prescription. Total substitution volume will be higher
           than 20 L per session.

           HDx will follow the same prescription of olHDF, regarding blood and dialysate flows and
           dialysis duration. There will be no substitution volume. Theranova™ dialyzers (Baxter
           Healthcare Corporation, Germany) will be used for each session.

           Before initiating protocol and during the washout period, patients will be submitted to
           high-flux HD, which is the standard treatment in our service.

        3. Hemodynamic monitoring Cardiac output index (CI), stroke volume (SV - integrated mean of
           the flow waveform between the current upstroke and the dichotic notch), peripheral
           arterial resistance (PAR - ratio of mean arterial pressure to stroke volume multiplied
           by heart rate) and blood pressure (BP) will be accessed by finger beat to-beat monitor
           Finometer™ (Finapress Medical Systems BV, Arnhem, The Netherlands), within 15 minutes
           after starting olHDF or HDx sessions (predialysis) and again, 15 minutes before its end
           (post-dialysis).

        4. Bioelectrical impedance Segmental tetrapolar bioelectrical impedance (BIS) will be
           performed in all patients while recumbent, before starting study protocol and before
           each phase of the study (HDx or olHDF), by the multifrequency InBody™ S10 (Biospace Co.,
           Ltd., Korea) device. It allows assessment of the following parameters regarding body
           fluids: total body water, total extracellular body water, lower limbs total water
           content, lower limbs extracellular water content. Additionally, α-angle, which is a
           marker of cellular integrity and nutritional status, will be noted.

        5. Blood and Effluent samples Blood samples will be collected pre-session, mid-session and
           post-dialysis sessions, both in the first and last dialysis sessions of each of the
           periods studied (HDFol or HDx). Pre-session blood samples will be collected immediately
           after arteriovenous fistula puncture and the middle and post-session samples will be
           collected from the arterial line, 2 minutes after reduction of blood flow to 50 ml/min
           and suspension of dialysate flow and/ or replacement.

      In addition, partial and homogeneous collection of the effluent will be performed by a
      drainage hose, with an infusion pump operating continuously at a rate of 1l/h. The whole
      effluent of dialysis session will be collected.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Investigator)
masking description: Investigator who collects laboratorial, hemodynamics and bioimpedance data will be blinded for intervention (online hemodiafiltration or expanded hemodialysis)
measure: Medium Molecule Clearance
time frame: One month after starting protocol
description: Beta-2-Microglobulin clearance
measure: Medium Molecule Removal
time frame: One month after starting protocol
description: Beta-2-Microglobulin extraction
measure: Intradialytic Hemodynamics
time frame: Cardiac output (liters per minute) one month after starting protocol
description: noninvasive cardiac output assessment
measure: Fluid Status
time frame: One month after starting protocol
description: noninvasive assessment of extracellular and total body water
arm group label: Online Hemodiafiltration
arm group type: Active Comparator
description: The olHDF technique combines diffusion with high convection rates in which the dialysis fluid, free of toxins and pyrogens, is used to prepare the replacement fluid.
The online module of dialysis machine prepares the replacement fluid by a cold sterilization process. There is a cross-flow water preparation, in order to avoid the accumulation of possible contaminants. The addition of bicarbonate and acid solutions to water follows the process. Next, the ready-for-infusion dialysis solution is passed through another ultrafilter prior to being infused into patients.
arm group label: Expanded Hemodialysis
arm group type: Experimental
description: More recently, membranes with high cutoff values, but with tight pore size distribution have been developed. The main concept is to keep both cutoff and retention onset values close to each other, but with a cutoff value lower than of albumin. This should allow removal of middle-to-high weight range uremic toxins, with very low albumin leak. Thus, these membranes, denominated high retention onset (HRO) membranes, allow performing both diffusive and convective processes in a conventional hemodialysis machine.
intervention type: Device
intervention name: Expanded Hemodialysis
description: Intervention: Conversion from conventional HD to expanded hemodialysis por 1 month.
High cutoff with high retention onset dialyzers allow clearance of middle molecules, without reducing significantly serum concentration of albumin. It allows higher convective clearance in comparison to conventional hemodialysis, but it is unknown if such clearance is similar to online hemodiafiltration. Therefore, the aim of the present intervention is to compare this dialyzer with online hemodiafiltration
arm group label: Expanded Hemodialysis
other name: Theranova Dialyzer
intervention type: Device
intervention name: Online Hemodiafiltration
description: Intervention: Conversion from conventional HD to online Hemodiafiltration por 1 month.
Online hemodiafiltration has been associated with lower incidence of intradialytic hypotension in comparison to conventional hemodialysis.
arm group label: Online Hemodiafiltration
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Bruno C Silva, PhD
role: Principal Investigator
affiliation: Renal Division, Unversity of São Paulo
facility: 
country: Brazil
citation: Karohl C, de Paiva Paschoal J, de Castro MC, Elias RM, Abensur H, Romao JE Jr, Passlick-Deetjen J, Jorgetti V, Moyses RM. Effects of bone remodelling on calcium mass transfer during haemodialysis. Nephrol Dial Transplant. 2010 Apr;25(4):1244-51. doi: 10.1093/ndt/gfp597. Epub 2010 Jan 29.
PMID: 20118484
citation: Cheng YL, Shek CC, Wong FK, Choi KS, Chau KF, Ing TS, Li CS. Determination of the solute removal index for urea by using a partial spent dialysate collection method. Am J Kidney Dis. 1998 Jun;31(6):986-90. doi: 10.1053/ajkd.1998.v31.pm9631843. Erratum In: Am J Kidney Dis 1998 Oct;32(4):704.
PMID: 9631843
citation: Alvares VRC, Ramos CD, Pereira BJ, Pinto AL, Moyses RMA, Gualano B, Elias RM. Pneumatic Compression, But Not Exercise, Can Avoid Intradialytic Hypotension: A Randomized Trial. Am J Nephrol. 2017;45(5):409-416. doi: 10.1159/000471513. Epub 2017 Apr 14.
PMID: 28407637
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responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Bruno Caldin da Silva
investigator title: Principal Investigator
mesh term: Hypotension
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The sample size was small and trial length was relatively short. We did not directly assessed albumin extraction. Besides, the relatively low ultrafiltration coefficient of both dialyzers limited dialysis performance in all treatment groups.
point of contact: 