<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/NCT03014232</url>
  </required_header>
  <id_info>
    <org_study_id>271/54</org_study_id>
    <nct_id>NCT03014232</nct_id>
  </id_info>
  <brief_title>Comparison Cytokine Clearance Between SLED-f Using High Cut-off Dialyzer and High-flux Dialyzer in Septic AKI Patients</brief_title>
  <official_title>Comparison Cytokine Clearance Between Sustained Low-Efficiency Diafiltration (SLED-f) Using High Cut-off Dialyzer and High-flux Dialyzer in Septic AKI Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chulalongkorn University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chulalongkorn University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypercytokinemia contributes a major role in the pathogenesis and is associated with the high&#xD;
      mortality in sepsis-related acute kidney injury(AKI). This pilot randomized controlled trial&#xD;
      was conducted in sepsis-related AKI patients to compare the efficacy of cytokine removal&#xD;
      including interleukin(IL)-6, IL-8, IL-10, and tumor necrotic factor(TNF)-α by six-hour SLED-f&#xD;
      between using HCO dialyzer(HCO-SLED-f) and HF dialyzer(HF-SLED-f).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypercytokinemia contributes a major role in the pathogenesis and is associated with the high&#xD;
      mortality in sepsis-related acute kidney injury(AKI). Reductions of these cytokines have been&#xD;
      reported to improve clinical outcomes. Online sustained low-efficiency diafiltration(SLED-f)&#xD;
      using traditional high-flux(HF) dialyzer could remove some cytokines. Interestingly, the&#xD;
      potential of enhancing cytokine removal by using newly designed high cut-off(HCO) dialyzer&#xD;
      that could theoretically remove larger molecular weight solutes has never been studied in&#xD;
      SLED-f before.This pilot randomized controlled trial was conducted in sepsis-related AKI&#xD;
      patients to compare the efficacy of cytokine removal including interleukin(IL)-6, IL-8,&#xD;
      IL-10, and tumor necrotic factor(TNF)-α by six-hour SLED-f between using HCO&#xD;
      dialyzer(HCO-SLED-f,n=8) and HF dialyzer(HF-SLED-f,n=8).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IL-6 Clearance</measure>
    <time_frame>At 30 minutes after the treatment was started</time_frame>
    <description>Simultaneous pre-and post-dialyzer blood samples from arterial and venous sampling ports were collected at 30 minutes after the treatment was started for determination of dialyzer clearances.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urea percentage of reduction ratio</measure>
    <time_frame>At time 0-hour and 6-hour of the study SLED-f session</time_frame>
    <description>Blood samples were taken from patients before and at the end of 6-hour in the first online SLED-f session. The percentage of reduction ratio were calculated from the before and ending samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beta2-microglobulin percentage of reduction ratio</measure>
    <time_frame>At time 0-hour and 6-hour of the study SLED-f session</time_frame>
    <description>Blood samples were taken from patients before and at the end of 6-hour in the first online SLED-f session. The percentage of reduction ratio were calculated from the before and ending samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-10 Clearances</measure>
    <time_frame>At 30 minutes after the treatment was started</time_frame>
    <description>Simultaneous pre-and post-dialyzer blood samples from arterial and venous sampling ports were collected at 30 minutes after the treatment was started for determination of dialyzer clearances.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TNF-α Clearances</measure>
    <time_frame>At 30 minutes after the treatment was started</time_frame>
    <description>Simultaneous pre-and post-dialyzer blood samples from arterial and venous sampling ports were collected at 30 minutes after the treatment was started for determination of dialyzer clearances.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intradialytic hypotension</measure>
    <time_frame>During 6 hours of SLED-f session</time_frame>
    <description>The hypotensive events were records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Albumin loss in spent dialysate</measure>
    <time_frame>During 6 hours of SLED-f session</time_frame>
    <description>Continuous sampling of spent effluent dialysate and ultrafiltrate were carried out with a collection pump inserted into the effluent outlet line via a special connector for total albumin loss determination</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Sepsis</condition>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>SLED-f with HCO dialyzer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Online sustained low-efficiency diafiltration (online SLED-f) using novel high cut-off dialyzer which had larger pore size than standard high-flux dialyzer was assigned as the new intervention to compare the efficacy of cytokine removals with the control arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SLED-f with HF dialyzer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Online sustained low-efficiency diafiltration (online SLED-f) using standard high-flux dialyzer in septic acute kidney injury patients was assigned as the control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SLED-f with HCO dialyzer</intervention_name>
    <description>Online SLED-f with high cut-off dialyzers were performed using the Fresenius 5008S hemodiafiltration machines (Fresenius Medical Care, Bad Homburg, Germany). Super-flux, Sureflux 150FH (Nipro Corporation, Osaka, Japan; cellulose triacetate material, pore size 78 A◦, Kuf 66.9 mL/hr/mmHg, surface area 1.5 m2) were used. Dialysis time and blood flow rate were 6 hours and 200 mL/min, respectively. The predilution reinfusion fluid rate and dialysate flow rate were 80 and 220 mL/min, respectively (the total dialysis fluid flow rate was 300 mL/min).</description>
    <arm_group_label>SLED-f with HCO dialyzer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SLED-f with HF dialyzer</intervention_name>
    <description>Online SLED-f with standard high-flux dialyzers were performed using the same Fresenius 5008S hemodiafiltration machines (Fresenius Medical Care, Bad Homburg, Germany). High-flux ELISIO 150H (Nipro Corporation, Osaka, Japan; polynephron material, pore size 50-60 A◦, Kuf 67 mL/hr/mmHg, surface area 1.5 m2) were used. Dialysis time and blood flow rate were 6 hours and 200 mL/min, respectively. The predilution reinfusion fluid rate and dialysate flow rate were 80 and 220 mL/min, respectively (the total dialysis fluid flow rate was 300 mL/min).</description>
    <arm_group_label>SLED-f with HF dialyzer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sepsis&#xD;
&#xD;
          -  Acute kidney injury stage 3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Profound hemodynamic instability with more than one inotropic drug&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Breast-feeding&#xD;
&#xD;
          -  Delayed receiving antibiotic up to 6 hours after beginning of septic shock.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Khajohn Tiranathanagul, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chulalongkorn University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeeraluk Tunpornchai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chulalongkorn University</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 5, 2017</last_update_submitted>
  <last_update_submitted_qc>January 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chulalongkorn University</investigator_affiliation>
    <investigator_full_name>Khajohn Tiranathanagul</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>sustained low-efficiency diafiltration (SLED-f)</keyword>
  <keyword>high cut-off dialyzer</keyword>
  <keyword>cytokines</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03014232
org study id: 271/54
nct id: NCT03014232
lead sponsor: 
has dmc: No
Hypercytokinemia contributes a major role in the pathogenesis and is associated with the high
      mortality in sepsis-related acute kidney injury(AKI). This pilot randomized controlled trial
      was conducted in sepsis-related AKI patients to compare the efficacy of cytokine removal
      including interleukin(IL)-6, IL-8, IL-10, and tumor necrotic factor(TNF)-α by six-hour SLED-f
      between using HCO dialyzer(HCO-SLED-f) and HF dialyzer(HF-SLED-f).
Hypercytokinemia contributes a major role in the pathogenesis and is associated with the high
      mortality in sepsis-related acute kidney injury(AKI). Reductions of these cytokines have been
      reported to improve clinical outcomes. Online sustained low-efficiency diafiltration(SLED-f)
      using traditional high-flux(HF) dialyzer could remove some cytokines. Interestingly, the
      potential of enhancing cytokine removal by using newly designed high cut-off(HCO) dialyzer
      that could theoretically remove larger molecular weight solutes has never been studied in
      SLED-f before.This pilot randomized controlled trial was conducted in sepsis-related AKI
      patients to compare the efficacy of cytokine removal including interleukin(IL)-6, IL-8,
      IL-10, and tumor necrotic factor(TNF)-α by six-hour SLED-f between using HCO
      dialyzer(HCO-SLED-f,n=8) and HF dialyzer(HF-SLED-f,n=8).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: IL-6 Clearance
time frame: At 30 minutes after the treatment was started
description: Simultaneous pre-and post-dialyzer blood samples from arterial and venous sampling ports were collected at 30 minutes after the treatment was started for determination of dialyzer clearances.
measure: Urea percentage of reduction ratio
time frame: At time 0-hour and 6-hour of the study SLED-f session
description: Blood samples were taken from patients before and at the end of 6-hour in the first online SLED-f session. The percentage of reduction ratio were calculated from the before and ending samples.
measure: Beta2-microglobulin percentage of reduction ratio
time frame: At time 0-hour and 6-hour of the study SLED-f session
description: Blood samples were taken from patients before and at the end of 6-hour in the first online SLED-f session. The percentage of reduction ratio were calculated from the before and ending samples.
measure: IL-10 Clearances
time frame: At 30 minutes after the treatment was started
description: Simultaneous pre-and post-dialyzer blood samples from arterial and venous sampling ports were collected at 30 minutes after the treatment was started for determination of dialyzer clearances.
measure: TNF-α Clearances
time frame: At 30 minutes after the treatment was started
description: Simultaneous pre-and post-dialyzer blood samples from arterial and venous sampling ports were collected at 30 minutes after the treatment was started for determination of dialyzer clearances.
measure: Intradialytic hypotension
time frame: During 6 hours of SLED-f session
description: The hypotensive events were records
measure: Albumin loss in spent dialysate
time frame: During 6 hours of SLED-f session
description: Continuous sampling of spent effluent dialysate and ultrafiltrate were carried out with a collection pump inserted into the effluent outlet line via a special connector for total albumin loss determination
arm group label: SLED-f with HCO dialyzer
arm group type: Experimental
description: Online sustained low-efficiency diafiltration (online SLED-f) using novel high cut-off dialyzer which had larger pore size than standard high-flux dialyzer was assigned as the new intervention to compare the efficacy of cytokine removals with the control arm.
arm group label: SLED-f with HF dialyzer
arm group type: Active Comparator
description: Online sustained low-efficiency diafiltration (online SLED-f) using standard high-flux dialyzer in septic acute kidney injury patients was assigned as the control group
intervention type: Procedure
intervention name: SLED-f with HCO dialyzer
description: Online SLED-f with high cut-off dialyzers were performed using the Fresenius 5008S hemodiafiltration machines (Fresenius Medical Care, Bad Homburg, Germany). Super-flux, Sureflux 150FH (Nipro Corporation, Osaka, Japan; cellulose triacetate material, pore size 78 A◦, Kuf 66.9 mL/hr/mmHg, surface area 1.5 m2) were used. Dialysis time and blood flow rate were 6 hours and 200 mL/min, respectively. The predilution reinfusion fluid rate and dialysate flow rate were 80 and 220 mL/min, respectively (the total dialysis fluid flow rate was 300 mL/min).
arm group label: SLED-f with HCO dialyzer
intervention type: Procedure
intervention name: SLED-f with HF dialyzer
description: Online SLED-f with standard high-flux dialyzers were performed using the same Fresenius 5008S hemodiafiltration machines (Fresenius Medical Care, Bad Homburg, Germany). High-flux ELISIO 150H (Nipro Corporation, Osaka, Japan; polynephron material, pore size 50-60 A◦, Kuf 67 mL/hr/mmHg, surface area 1.5 m2) were used. Dialysis time and blood flow rate were 6 hours and 200 mL/min, respectively. The predilution reinfusion fluid rate and dialysate flow rate were 80 and 220 mL/min, respectively (the total dialysis fluid flow rate was 300 mL/min).
arm group label: SLED-f with HF dialyzer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Khajohn Tiranathanagul, MD
role: Principal Investigator
affiliation: Chulalongkorn University
last name: Jeeraluk Tunpornchai, MD
role: Principal Investigator
affiliation: Chulalongkorn University
responsible party type: Principal Investigator
investigator affiliation: Chulalongkorn University
investigator full name: Khajohn Tiranathanagul
investigator title: Assistant Professor
mesh term: Acute Kidney Injury
sharing ipd: No