<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/NCT03263325</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00025852</org_study_id>
    <nct_id>NCT03263325</nct_id>
  </id_info>
  <brief_title>Evaluation of UDP-glucose as a Urinary Biomarker for Early Detection of Cardiac Surgery-associated Pediatric Acute Kidney Injury</brief_title>
  <official_title>Evaluation of UDP-glucose as a Urinary Biomarker for Early Detection of Cardiac Surgery-associated Pediatric Acute Kidney Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Children's Hospital</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>
      Acute kidney injury (AKI) is common in children after cardiac surgery with a reported&#xD;
      incidence of 20-40%. Pediatric AKI has been found to be associated with important short and&#xD;
      long-term adverse outcomes.&#xD;
&#xD;
      A major challenge to management of AKI after cardiac surgery and cardiopulmonary bypass is&#xD;
      the lack of early diagnostic markers. Current diagnostic criteria for AKI in children relies&#xD;
      exclusively on elevation of serum creatinine concentration and oliguria. Both of these&#xD;
      markers lack sensitivity and specificity, and result in delayed detection of kidney injury.&#xD;
&#xD;
      This study aims to determine if UDP-glucose can be used as a urinary biomarker to detect&#xD;
      subclinical acute kidney injury following pediatric cardiac surgery with cardiopulmonary&#xD;
      bypass.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 25, 2017</start_date>
  <completion_date type="Anticipated">August 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2023</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>AKI</measure>
    <time_frame>within 72 hours after surgery</time_frame>
    <description>development of AKI</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>AKI Group</arm_group_label>
    <description>Patients developing AKI after surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No AKI Group</arm_group_label>
    <description>Patients who do not develop AKI after surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Discarded urine sample</intervention_name>
    <description>Collection of discarded urine during surgery and following surgery</description>
    <arm_group_label>AKI Group</arm_group_label>
    <arm_group_label>No AKI Group</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine Samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Children ≤ 8 years of age having cardiac surgery with cardiopulmonary bypass&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  less than or equal to 8 years of age&#xD;
&#xD;
          -  scheduled for cardiac surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe pre-existing renal insufficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Douglas Atkinson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Douglas Atkinson, MD</last_name>
    <phone>617-355-6225</phone>
    <email>Douglas.Atkinson@childrens.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rachel Bernier, MPH</last_name>
    <phone>857-218-5348</phone>
    <email>Rachel.Bernier@childrens.harvard.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Douglas Atkinson, MD</last_name>
      <phone>617-355-6225</phone>
      <email>douglas.atkinson@childrens.harvard.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>February 16, 2023</last_update_submitted>
  <last_update_submitted_qc>February 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Douglas Atkinson</investigator_full_name>
    <investigator_title>Cardiac Anesthesiologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT03263325
org study id: IRB-P00025852
nct id: NCT03263325
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Acute kidney injury (AKI) is common in children after cardiac surgery with a reported
      incidence of 20-40%. Pediatric AKI has been found to be associated with important short and
      long-term adverse outcomes.

      A major challenge to management of AKI after cardiac surgery and cardiopulmonary bypass is
      the lack of early diagnostic markers. Current diagnostic criteria for AKI in children relies
      exclusively on elevation of serum creatinine concentration and oliguria. Both of these
      markers lack sensitivity and specificity, and result in delayed detection of kidney injury.

      This study aims to determine if UDP-glucose can be used as a urinary biomarker to detect
      subclinical acute kidney injury following pediatric cardiac surgery with cardiopulmonary
      bypass.
observational model: Cohort
time perspective: Prospective
measure: AKI
time frame: within 72 hours after surgery
description: development of AKI
arm group label: AKI Group
description: Patients developing AKI after surgery
arm group label: No AKI Group
description: Patients who do not develop AKI after surgery
intervention type: Other
intervention name: Discarded urine sample
description: Collection of discarded urine during surgery and following surgery
arm group label: AKI Group
arm group label: No AKI Group
Urine Samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 8 Years
healthy volunteers: No
last name: Douglas Atkinson, MD
role: Principal Investigator
affiliation: Boston Children's Hospital
last name: Douglas Atkinson, MD
phone: 617-355-6225
email: Douglas.Atkinson@childrens.harvard.edu
last name: Rachel Bernier, MPH
phone: 857-218-5348
email: Rachel.Bernier@childrens.harvard.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Douglas Atkinson
investigator title: Cardiac Anesthesiologist
mesh term: Acute Kidney Injury
mesh term: Wounds and Injuries
sharing ipd: No