<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/NCT02998346</url>
  </required_header>
  <id_info>
    <org_study_id>13-009155</org_study_id>
    <nct_id>NCT02998346</nct_id>
  </id_info>
  <brief_title>Systemic Metabolic Contribution From Continuous Renal Replacement Therapy (CRRT)</brief_title>
  <official_title>Quantification of Systemic Metabolic Contribution From Continuous Renal Replacement Therapy (CRRT) Utilizing Regional Citrate Anticoagulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this observational study is to measure the number of calories delivered from&#xD;
      fluids used in continuous renal replacement therapy (CRRT). We are doing this research study&#xD;
      because the fluids used in this treatment may deliver an important number of calories. In the&#xD;
      future this could help better estimate how much nutrition patients in the Critical Care Unit&#xD;
      should get every day from other sources like tube feeding or nutrition through a person's&#xD;
      veins.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to quantify the specific metabolic contribution of standard&#xD;
      continuous renal replacement protocols (including citrate anticoagulation) in the intensive&#xD;
      care unit patient population at Mayo Clinic in Rochester, Minnesota utilizing a prospective,&#xD;
      observational study. This data will allow practitioners to better tailor caloric provision&#xD;
      with nutrition support programs, minimizing the risk of overfeeding in this complex critical&#xD;
      care patient population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">June 28, 2017</completion_date>
  <primary_completion_date type="Actual">June 28, 2017</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>Quantify net glucose uptake from citrate and dextrose-containing fluids from continuous venovenous hemofiltration</measure>
    <time_frame>Two days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantify net citrate uptake from citrate and dextrose-containing fluids from continuous venovenous hemofiltration</measure>
    <time_frame>Two days</time_frame>
  </primary_outcome>
  <enrollment type="Actual">10</enrollment>
  <condition>Acute Kidney Injury</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Critically ill patients initiated on continuous venovenous hemofiltration receiving&#xD;
        regional citrate anticoagulation with ACD-A solution.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than or equal to 18 years&#xD;
&#xD;
          -  Patients in an intensive care unit anticipated to receive greater than or equal to 24&#xD;
             hours of continuous venovenous hemofiltration.&#xD;
&#xD;
          -  Receiving regional citrate anticoagulation with ACD-A solution.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vulnerable adults&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  BMI &gt; 40&#xD;
&#xD;
          -  Patient on extracorporeal membrane oxygenation therapy&#xD;
&#xD;
          -  Reversal of port connections on the dialysis catheter and dialysis circuit lines&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>January 29, 2018</last_update_submitted>
  <last_update_submitted_qc>January 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Erin Nystrom</investigator_full_name>
    <investigator_title>Assistant Professor of Pharmacy</investigator_title>
  </responsible_party>
  <keyword>Nutrition</keyword>
  <keyword>CRRT</keyword>
  <keyword>CVVH</keyword>
  <keyword>citrate</keyword>
  <keyword>anticoagulation</keyword>
  <keyword>caloric uptake</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/NCT02998346
org study id: 13-009155
nct id: NCT02998346
lead sponsor: 
has dmc: No
The purpose of this observational study is to measure the number of calories delivered from
      fluids used in continuous renal replacement therapy (CRRT). We are doing this research study
      because the fluids used in this treatment may deliver an important number of calories. In the
      future this could help better estimate how much nutrition patients in the Critical Care Unit
      should get every day from other sources like tube feeding or nutrition through a person's
      veins.
The goal of this study is to quantify the specific metabolic contribution of standard
      continuous renal replacement protocols (including citrate anticoagulation) in the intensive
      care unit patient population at Mayo Clinic in Rochester, Minnesota utilizing a prospective,
      observational study. This data will allow practitioners to better tailor caloric provision
      with nutrition support programs, minimizing the risk of overfeeding in this complex critical
      care patient population.
observational model: Cohort
time perspective: Prospective
measure: Quantify net glucose uptake from citrate and dextrose-containing fluids from continuous venovenous hemofiltration
time frame: Two days
measure: Quantify net citrate uptake from citrate and dextrose-containing fluids from continuous venovenous hemofiltration
time frame: Two days
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Erin Nystrom
investigator title: Assistant Professor of Pharmacy
mesh term: Acute Kidney Injury
sharing ipd: No