<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/NCT03231748</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS ID: 196972</org_study_id>
    <nct_id>NCT03231748</nct_id>
  </id_info>
  <brief_title>Clearance of Inflammatory Cytokines During Renal Replacement Therapy Using the EMIC®2 Filter</brief_title>
  <acronym>ClicAKI</acronym>
  <official_title>Clearance of Inflammatory Cytokines in Patients With Septic Acute Kidney Injury During Renal Replacement Therapy Using the EMIC®2 Filter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guy's and St Thomas' NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guy's and St Thomas' NHS Foundation Trust</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>
      This study will be conducted in patients with sepsis and acute kidney injury needing renal&#xD;
      replacement therapy.&#xD;
&#xD;
      The aim is to investigate whether continuous renal replacement therapy with the EMIC®2 filter&#xD;
      leads to removal of pro-inflammatory middle molecular weight cytokines from the blood.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In patients with acute kidney injury (AKI) and sepsis requiring renal replacement therapy,&#xD;
      the investigators aim to determine whether continuous veno-venous haemodialysis with an&#xD;
      EMiC®2 filter leads to clearance of the following mediators Interleukin (IL) -1 alpha, IL-1&#xD;
      beta, IL-2, IL- 4, IL-6, IL-8, IL-10, Tissue necrosis factor alpha (TNF-α), vascular&#xD;
      endothelial growth factor (VEGF), Interferon gamma, Monocyte chemotactic protein-1 and&#xD;
      epidermal growth factor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">July 1, 2018</completion_date>
  <primary_completion_date type="Actual">July 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Removal of inflammatory mediators</measure>
    <time_frame>48 hours</time_frame>
    <description>Clearance of the following mediators Interleukin (IL) -1 alpha, IL-1 beta, IL-2, IL- 4, IL-6, IL-8, IL-10, Tissue necrosis factor alpha (TNF-α), vascular endothelial growth factor (VEGF), Interferon gamma, Monocyte chemotactic protein-1 and epidermal growth factor</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adsorption of inflammatory mediators</measure>
    <time_frame>48 hours</time_frame>
    <description>Adsorption of IL-1 alpha, IL-1 beta, IL-2, IL- 4, IL-6, IL-8, IL-10, Tissue necrosis factor alpha (TNF-α), vascular endothelial growth factor (VEGF), Interferon gamma, Monocyte chemotactic protein-1 and epidermal growth factor</description>
  </secondary_outcome>
  <enrollment type="Actual">12</enrollment>
  <condition>Acute Renal Failure</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with sepsis and acute kidney injury who require renal replacement therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients (≥18 years) in the Critical Care Unit with AKI and sepsis&#xD;
&#xD;
          -  clinical decision that citrate based continuous veno-venous haemodialysis (CVVHD) is&#xD;
             necessary&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lack of consent&#xD;
&#xD;
          -  pre-existing dialysis dependent renal failure&#xD;
&#xD;
          -  life expectancy &lt;24 hours&#xD;
&#xD;
          -  patients with haemoglobin &lt;7g/dL (unless transfused for clinical reasons)&#xD;
&#xD;
          -  need for extracorporeal membrane oxygenation (ECMO)&#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>Marlies Ostermann, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Guy's &amp; St Thomas Hospital London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guy's &amp; St Thomas Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>July 10, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>October 21, 2019</last_update_submitted>
  <last_update_submitted_qc>October 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03231748
org study id: IRAS ID: 196972
nct id: NCT03231748
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will be conducted in patients with sepsis and acute kidney injury needing renal
      replacement therapy.

      The aim is to investigate whether continuous renal replacement therapy with the EMIC®2 filter
      leads to removal of pro-inflammatory middle molecular weight cytokines from the blood.
In patients with acute kidney injury (AKI) and sepsis requiring renal replacement therapy,
      the investigators aim to determine whether continuous veno-venous haemodialysis with an
      EMiC®2 filter leads to clearance of the following mediators Interleukin (IL) -1 alpha, IL-1
      beta, IL-2, IL- 4, IL-6, IL-8, IL-10, Tissue necrosis factor alpha (TNF-α), vascular
      endothelial growth factor (VEGF), Interferon gamma, Monocyte chemotactic protein-1 and
      epidermal growth factor.
observational model: Cohort
time perspective: Prospective
measure: Removal of inflammatory mediators
time frame: 48 hours
description: Clearance of the following mediators Interleukin (IL) -1 alpha, IL-1 beta, IL-2, IL- 4, IL-6, IL-8, IL-10, Tissue necrosis factor alpha (TNF-α), vascular endothelial growth factor (VEGF), Interferon gamma, Monocyte chemotactic protein-1 and epidermal growth factor
measure: Adsorption of inflammatory mediators
time frame: 48 hours
description: Adsorption of IL-1 alpha, IL-1 beta, IL-2, IL- 4, IL-6, IL-8, IL-10, Tissue necrosis factor alpha (TNF-α), vascular endothelial growth factor (VEGF), Interferon gamma, Monocyte chemotactic protein-1 and epidermal growth factor
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marlies Ostermann, PhD
role: Study Director
affiliation: Guy's & St Thomas Hospital London
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Acute Kidney Injury