<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/NCT03025659</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201601991</org_study_id>
    <nct_id>NCT03025659</nct_id>
  </id_info>
  <brief_title>Lactate Acidosis in Postoperative Hearts</brief_title>
  <official_title>Characterization of Lactic Acidosis in Pediatric Postoperative Cardiac Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</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 is a single-center, observational study. Investigators aim to characterize the&#xD;
      metabolism of lactate in children over the first forty-eight hours following cardiac surgery.&#xD;
      Blood samples will be obtained up to 12 timepoints. Samples will be analyzed for&#xD;
      concentration of pyruvate. Results will be compared to standard of care laboratory results&#xD;
      for lactate and other direct and indirect measures of cardiac output.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators will characterize the etiologies of hyperlactatemia predominantly present at&#xD;
      serial postoperative timepoints in children recovering from cardiac surgery by following&#xD;
      lactate levels and the lactate-to-pyruvate ratio over the first 48 post-operative hours and&#xD;
      correlating them with cardiac output as determined by conventional markers and physical exam.&#xD;
      Investigators expect to validate the assumption that in children recovering from heart&#xD;
      surgery whose cardiac output is apparently normal, hyperlactatemia (if seen) is predominantly&#xD;
      due to impaired lactate clearance or metabolism, while in those whose cardiac output is low,&#xD;
      it is predominantly due to inadequate oxygen delivery. Blood samples will be obtained up to&#xD;
      12 timepoints (arrival at the intensive care unit postoperatively, hour 1, hour 2, hour 3,&#xD;
      hour 4, hour 6, hour 8, hour 10, hour 12, hour 24, hour 36 and hour 48 postoperative) or only&#xD;
      at up to 6 time points (approximately Hour 0, 2, 4, 6, 8, and 12) for infants under 10 kg as&#xD;
      described below. . Samples will be analyzed for concentration of pyruvate. Results will be&#xD;
      compared to standard of care laboratory results for lactate and other direct and indirect&#xD;
      measures of cardiac output.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 28, 2017</start_date>
  <completion_date type="Actual">January 24, 2019</completion_date>
  <primary_completion_date type="Actual">January 24, 2019</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>Lactate/pyruvate ratio</measure>
    <time_frame>Hourly, assessed up to 48 hours</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">43</enrollment>
  <condition>Post-cardiac Surgery</condition>
  <condition>Hyperlactatemia</condition>
  <arm_group>
    <arm_group_label>Pediatric post-cardiac surgery</arm_group_label>
    <description>All immediately post-operative pediatric cardiac patients will be enrolled. Standard of care laboratory analysis will be performed based on current clinical protocols. Results for lactate, blood gases, liver enzymes, creatinine, glucose, hemoglobin, hematocrit and other direct and indirect measure of cardiac output will be collected. Investigators will also measure pyruvate levels at specific time points, which is not part of standard of care. To measure pyruvate, an additional 1 ml of arterial blood will be drawn at each routine postoperative blood draw. The lactate/pyruvate ratio will be calculated and compared to direct and indirect measure of cardiac output described above.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pyruvate levels</intervention_name>
    <description>An additional 1 ml of arterial blood will be drawn at each routine postoperative blood draw (Hour 0, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 for participants 10kg and above or only at Hour 0, 2, 4, 6, 8, and 12 for infants under 10 kg) to measure the concentration of pyruvate in blood.</description>
    <arm_group_label>Pediatric post-cardiac surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric cardiac surgical patients at UF Health Shands Children's Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All immediately post-operative cardiac patients admitted to the pediatric cardiac&#xD;
             intensive care unit (PCICU)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of parental or patient consent, or patient assent when applicable, including&#xD;
             non-English speakers and wards of the state&#xD;
&#xD;
          -  Dosing weight less than 4 kg*&#xD;
&#xD;
          -  Cardiac catheterization being the only operative procedure&#xD;
&#xD;
          -  Severe hepatic dysfunction at any time during the hospital course&#xD;
&#xD;
          -  Seizures during the study period&#xD;
&#xD;
          -  Sepsis during the study period&#xD;
&#xD;
          -  Need for extracorporeal membrane oxygenation or continuous renal replacement therapy&#xD;
&#xD;
          -  Known congenital myopathy, ataxia, polyneuropathies or inborn errors of metabolism&#xD;
             including congenital lactic acidosis and other mitochondrial disorders&#xD;
&#xD;
          -  Primary hypoventilation&#xD;
&#xD;
          -  Malignancies&#xD;
&#xD;
          -  Fanconi syndrome&#xD;
&#xD;
          -  Wernicke encephalopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael D Tsifansky, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida Shands Children's Hospital</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>March 20, 2020</last_update_submitted>
  <last_update_submitted_qc>March 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pediatric</keyword>
  <keyword>congenital heart disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acidosis</mesh_term>
    <mesh_term>Hyperlactatemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be collected on REDCap (secure web application for building and managing online surveys and databases) and available to study staff via password protected access</ipd_description>
  </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/NCT03025659
org study id: IRB201601991
nct id: NCT03025659
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a single-center, observational study. Investigators aim to characterize the
      metabolism of lactate in children over the first forty-eight hours following cardiac surgery.
      Blood samples will be obtained up to 12 timepoints. Samples will be analyzed for
      concentration of pyruvate. Results will be compared to standard of care laboratory results
      for lactate and other direct and indirect measures of cardiac output.
Investigators will characterize the etiologies of hyperlactatemia predominantly present at
      serial postoperative timepoints in children recovering from cardiac surgery by following
      lactate levels and the lactate-to-pyruvate ratio over the first 48 post-operative hours and
      correlating them with cardiac output as determined by conventional markers and physical exam.
      Investigators expect to validate the assumption that in children recovering from heart
      surgery whose cardiac output is apparently normal, hyperlactatemia (if seen) is predominantly
      due to impaired lactate clearance or metabolism, while in those whose cardiac output is low,
      it is predominantly due to inadequate oxygen delivery. Blood samples will be obtained up to
      12 timepoints (arrival at the intensive care unit postoperatively, hour 1, hour 2, hour 3,
      hour 4, hour 6, hour 8, hour 10, hour 12, hour 24, hour 36 and hour 48 postoperative) or only
      at up to 6 time points (approximately Hour 0, 2, 4, 6, 8, and 12) for infants under 10 kg as
      described below. . Samples will be analyzed for concentration of pyruvate. Results will be
      compared to standard of care laboratory results for lactate and other direct and indirect
      measures of cardiac output.
observational model: Cohort
time perspective: Prospective
measure: Lactate/pyruvate ratio
time frame: Hourly, assessed up to 48 hours
arm group label: Pediatric post-cardiac surgery
description: All immediately post-operative pediatric cardiac patients will be enrolled. Standard of care laboratory analysis will be performed based on current clinical protocols. Results for lactate, blood gases, liver enzymes, creatinine, glucose, hemoglobin, hematocrit and other direct and indirect measure of cardiac output will be collected. Investigators will also measure pyruvate levels at specific time points, which is not part of standard of care. To measure pyruvate, an additional 1 ml of arterial blood will be drawn at each routine postoperative blood draw. The lactate/pyruvate ratio will be calculated and compared to direct and indirect measure of cardiac output described above.
intervention type: Other
intervention name: Pyruvate levels
description: An additional 1 ml of arterial blood will be drawn at each routine postoperative blood draw (Hour 0, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 for participants 10kg and above or only at Hour 0, 2, 4, 6, 8, and 12 for infants under 10 kg) to measure the concentration of pyruvate in blood.
arm group label: Pediatric post-cardiac surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 21 Years
healthy volunteers: No
last name: Michael D Tsifansky, MD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acidosis
mesh term: Hyperlactatemia
sharing ipd: Yes
ipd description: Data will be collected on REDCap (secure web application for building and managing online surveys and databases) and available to study staff via password protected access