<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/NCT04458571</url>
  </required_header>
  <id_info>
    <org_study_id>18-0405</org_study_id>
    <nct_id>NCT04458571</nct_id>
  </id_info>
  <brief_title>Effect of CRRT Duration on Solute Removal</brief_title>
  <official_title>Effect of CRRT Duration on Solute Removal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The only FDA approved treatment for acute kidney injury(AKI) for patients is Dialysis-also&#xD;
      known as renal replacement therapy(RRT). Continuous RRT(CRRT) is the preferred method in the&#xD;
      ICU. Patients receiving CRRT with AKI will be recruited to the study where blood and effluent&#xD;
      will be collect prior to CRRT initiation and Day 1,2,and 3 following. Metabolites will be&#xD;
      assessed to determine solute removal, and also to identify the time at which solute removal&#xD;
      has reached steady state. This will help determine the best duration of CRRT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute kidney injury (AKI) occurs in 30-50% of hospitalized patients admitted to the intensive&#xD;
      care unit (ICU). Dialysis - also known as renal replacement therapy (RRT) - is the only FDA&#xD;
      approved treatment for AKI and continuous RRT (CRRT) is generally the preferred method of RRT&#xD;
      in the ICU. The in-hospital mortality of patients with AKI requiring dialysis in the ICU is&#xD;
      over 50% which is much greater than other serious illnesses.Unfortunately, the quality of&#xD;
      care delivered to patients with AKI receiving CRRT is poor due to practice variability and&#xD;
      lack of quality indicators to assess CRRT performance. Since one of the fundamental purposes&#xD;
      of CRRT is to remove the build-up of metabolites that accumulate during AKI, accurate methods&#xD;
      to assess solute clearance would be especially valuable. Indeed, development of methods to&#xD;
      assess solute clearance during CRRT has been identified as a research priority. Although&#xD;
      changes in plasma creatinine has been suggested as a potential quality indicator of solute&#xD;
      removal during CRRT, no study has assessed how reductions of plasma creatinine over time&#xD;
      compare to the reductions of other plasma metabolites. Thus, the duration of CRRT necessary&#xD;
      to achieve adequate solute removal is unknown - in fact, there is not yet even an agreed-upon&#xD;
      working definition of what adequate solute removal during CRRT should be. The investigators&#xD;
      propose to conduct a prospective, single center study of 112 CRRT patients to determine the&#xD;
      effect of CRRT duration on solute removal in order to identify the time at which solute&#xD;
      removal has reached steady state. To assess solute removal, 102 metabolites will be&#xD;
      determined in the plasma and effluent via untargeted ultra high pressure liquid&#xD;
      chromatography coupled to mass spectrometry (UHPLC-MS). Metabolites will be assessed on&#xD;
      plasma collected immediately prior to CRRT initiation, and on plasma and effluent collected&#xD;
      on days 1, 2, and 3 post-CRRT initiation. Steady state is defined as the time point at which&#xD;
      a plasma metabolite is not significantly reduced during CRRT - as assessed over a 24 hour&#xD;
      time period. Based on preliminary data, the investigators hypothesize that &gt;90% of&#xD;
      metabolites will reach steady state by day 2 of CRRT, and that &gt;95% of metabolites will reach&#xD;
      steady state by day 3 of CRRT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Actual">December 21, 2022</completion_date>
  <primary_completion_date type="Actual">December 21, 2022</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>Steady State Metabolites</measure>
    <time_frame>3 years</time_frame>
    <description>The primary outcome of interest is the binary identification of steady state for each metabolite. Approximately 100 metabolites will be measured including amino acids, phosphorus, creatinine, and BUN</description>
  </primary_outcome>
  <enrollment type="Actual">112</enrollment>
  <condition>AKI</condition>
  <condition>Sepsis</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood samples and Effluent&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients admitted to University of Colorado Hospital and being initiated on CRRT.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients being initiated on CRRT at University of Colorado Hospital (UCH)&#xD;
             will be considered for enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vulnerable populations such as children, pregnant women, and prisoners will be&#xD;
             excluded.&#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>Sarah Faubel</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado - Anschutz Medical Campus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>February 10, 2023</last_update_submitted>
  <last_update_submitted_qc>February 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04458571
org study id: 18-0405
nct id: NCT04458571
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The only FDA approved treatment for acute kidney injury(AKI) for patients is Dialysis-also
      known as renal replacement therapy(RRT). Continuous RRT(CRRT) is the preferred method in the
      ICU. Patients receiving CRRT with AKI will be recruited to the study where blood and effluent
      will be collect prior to CRRT initiation and Day 1,2,and 3 following. Metabolites will be
      assessed to determine solute removal, and also to identify the time at which solute removal
      has reached steady state. This will help determine the best duration of CRRT.
Acute kidney injury (AKI) occurs in 30-50% of hospitalized patients admitted to the intensive
      care unit (ICU). Dialysis - also known as renal replacement therapy (RRT) - is the only FDA
      approved treatment for AKI and continuous RRT (CRRT) is generally the preferred method of RRT
      in the ICU. The in-hospital mortality of patients with AKI requiring dialysis in the ICU is
      over 50% which is much greater than other serious illnesses.Unfortunately, the quality of
      care delivered to patients with AKI receiving CRRT is poor due to practice variability and
      lack of quality indicators to assess CRRT performance. Since one of the fundamental purposes
      of CRRT is to remove the build-up of metabolites that accumulate during AKI, accurate methods
      to assess solute clearance would be especially valuable. Indeed, development of methods to
      assess solute clearance during CRRT has been identified as a research priority. Although
      changes in plasma creatinine has been suggested as a potential quality indicator of solute
      removal during CRRT, no study has assessed how reductions of plasma creatinine over time
      compare to the reductions of other plasma metabolites. Thus, the duration of CRRT necessary
      to achieve adequate solute removal is unknown - in fact, there is not yet even an agreed-upon
      working definition of what adequate solute removal during CRRT should be. The investigators
      propose to conduct a prospective, single center study of 112 CRRT patients to determine the
      effect of CRRT duration on solute removal in order to identify the time at which solute
      removal has reached steady state. To assess solute removal, 102 metabolites will be
      determined in the plasma and effluent via untargeted ultra high pressure liquid
      chromatography coupled to mass spectrometry (UHPLC-MS). Metabolites will be assessed on
      plasma collected immediately prior to CRRT initiation, and on plasma and effluent collected
      on days 1, 2, and 3 post-CRRT initiation. Steady state is defined as the time point at which
      a plasma metabolite is not significantly reduced during CRRT - as assessed over a 24 hour
      time period. Based on preliminary data, the investigators hypothesize that >90% of
      metabolites will reach steady state by day 2 of CRRT, and that >95% of metabolites will reach
      steady state by day 3 of CRRT.
observational model: Cohort
time perspective: Prospective
measure: Steady State Metabolites
time frame: 3 years
description: The primary outcome of interest is the binary identification of steady state for each metabolite. Approximately 100 metabolites will be measured including amino acids, phosphorus, creatinine, and BUN
Whole blood samples and Effluent
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sarah Faubel
role: Principal Investigator
affiliation: University of Colorado - Anschutz Medical Campus
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided