<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/NCT04466306</url>
  </required_header>
  <id_info>
    <org_study_id>ChildrensHA</org_study_id>
    <nct_id>NCT04466306</nct_id>
  </id_info>
  <brief_title>Pediatric Acute Kidney Injury in COVID-19</brief_title>
  <acronym>SPARC-1</acronym>
  <official_title>SARS-CoV2 Pediatric Acute Kidney Injury Registry and Collaborative</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Healthcare of Atlanta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's of Alabama</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Healthcare of Atlanta</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>
      This study is an observational registry of children with or suspected to have SARS CoV2&#xD;
      (COVID-19) admitted to pediatric intensive care units (PICU). This registry will help&#xD;
      describe the prevalence, rate and severity of acute kidney injury (AKI) in children with&#xD;
      Severe Acute Respiratory Syndrome Coronavirus-2(SARS CoV2) across the world. The registry&#xD;
      will be developed using a point prevalence methodology and then full retrospective review.&#xD;
      Once a week, from April through June 2020, data collection will occur in &quot;real-time&quot; to&#xD;
      estimate a weekly point prevalence of AKI and renal replacement therapy (RRT). The&#xD;
      operational definition of &quot;patients under investigation&quot; (PUIs) will be used to identify the&#xD;
      denominator of patients to be studied. The PUIs will be cohorted into SARS CoV2 test&#xD;
      positive, test negative, test pending, or test unavailable. The primary aim of this study is&#xD;
      to deliver a global, objective data driven analysis of the burden of AKI in virus positive&#xD;
      patients or patients under investigation (PUI) who are admitted to the pediatric intensive&#xD;
      care unit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary purpose of the data collection will be to provide a descriptive analysis of the&#xD;
      burden and characteristics of AKI in children with SARS-CoV2 proven or suspected infection&#xD;
      across the world. This is a prospective, point prevalence study. Data collection will occur&#xD;
      once a week during the months of April through June 2020.&#xD;
&#xD;
      The protocol for the point prevalence is for each individual participating site to conduct a&#xD;
      surveillance study on predetermined dates of their intensive care units (pediatric medical,&#xD;
      surgical, cardiac ICUs) for patients by the inclusion and exclusion criteria. The study is&#xD;
      strictly observational. Data will only be captured on the predetermined dates listed. The&#xD;
      dates have been chosen to reflect the estimated surge and peak of the virus spread in North&#xD;
      America, Europe, Africa, Asia, and Australia. The rationale for performing an urgent point&#xD;
      prevalence estimation study first, includes the following: a) there is almost no knowledge on&#xD;
      AKI rate, severity of AKI or how current pandemic-setting AKI phenotype differs from what we&#xD;
      know of AKI in children prior to the pandemic. A rapidly-performed, high feasibility-designed&#xD;
      point prevalence estimation study, with minimal data collection will provide rapid, almost&#xD;
      instantaneous dissemination of results to the international community. Based on the results&#xD;
      of this study, a follow-up study is planned for a full retrospective data collection of all&#xD;
      viral positive patients. Understanding the burden of pediatric AKI during this pandemic&#xD;
      within the current context of acute health burden in the healthcare settings and enable&#xD;
      planning and feasibility evaluation for quality of care measures and potentially for upcoming&#xD;
      technology needs and/or sharing of RRT technology with adult care units; b) an urgent&#xD;
      point-prevalence estimation study with minimal but key data collection will inform on any&#xD;
      changes to design, sample size requirements or data points for the larger granular&#xD;
      longitudinal retrospective study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2020</start_date>
  <completion_date type="Actual">July 1, 2021</completion_date>
  <primary_completion_date type="Actual">July 1, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>14 Days</target_duration>
  <primary_outcome>
    <measure>Acute Kidney Injury (AKI)</measure>
    <time_frame>14 days</time_frame>
    <description>Kidney Disease Improving Global Outcomes (KDIGO) Staged AKI by serum creatinine or urine output</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>14 days</time_frame>
    <description>Survival to ICU discharge or Day 14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Extracorporeal Therapy Requirement</measure>
    <time_frame>14 days</time_frame>
    <description>The use of extracorporeal membrane oxygenation (ECMO) and/or renal replacement therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluid overload</measure>
    <time_frame>Day of Enrollment</time_frame>
    <description>&gt;20% fluid overload as defined as the net fluid balance since ICU admission (in liters) divided by ICU admission weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of nephrotoxic medication exposure</measure>
    <time_frame>Day of Enrollment</time_frame>
    <description>The exposure of enrolled patients to known nephrotoxic medications, including diuretics</description>
  </secondary_outcome>
  <enrollment type="Actual">400</enrollment>
  <condition>Acute Kidney Injury</condition>
  <condition>COVID</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to the pediatric medical, surgical, or cardiac ICU for any condition -&#xD;
        with a suspicion for or proven diagnosis of SARS-COV2 (COVID-19).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient less than or equal to 25 years of age&#xD;
&#xD;
          -  Receiving clinical care in the pediatric intensive care unit (PICU) on a study day in&#xD;
             April - June 2020&#xD;
&#xD;
          -  Patient considered a &quot;Person Under Investigation&quot; and/or tested positive for SARS-CoV2&#xD;
             (COVID-19)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Days</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rajit K Basu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Healthcare of Atlanta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Alabama</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkansas Children's Research Institute</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedars-Sinai Maxine Dunitz Children's Health Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Mattel Children's Hospital</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lucile Packard Children's Hospital Standford</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rady Children's Hospital San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale New Haven Children's Hospital</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UF Health Shands Children's Hospital</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Healthcare of Atlanta</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comer Children's Hospital - UChicago Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riley Hospital for Children</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Stead Family Children's Hospital</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Mercy</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Hopkins Children's Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.S. Mott Children's Hospital</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helen DeVos Children's Hospital</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont Children's Hospital</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis Children's Hospital of Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oishei Children's Hospital of Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Golisano Children's Hospital - University of Rochester Medicine</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook Children's Hospital</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Levine Children's Hospital</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Children's Hospital and Health Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Children's Hospital</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Children's Hospital of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lifespan Hasbro Children's Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina Shawn Jenkins Children's Hospital</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stollery Children's Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McMaster Children's Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 3Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hospital for Sick Children (SickKids)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soroka University Medical Center</name>
      <address>
        <city>Be'er Sheva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Dwek Children's Hospital</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shizuoka Children's Hospital</name>
      <address>
        <city>Shizuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Mother and Child Healthcare</name>
      <address>
        <city>Belgrade</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Children's Hospital</name>
      <address>
        <city>Belgrade</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham Children's Hospital NHS</name>
      <address>
        <city>Birmingham</city>
        <zip>B4 6NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alder Hey Children's Hospital NHS</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital NHS</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. George's University Hospital NHS</name>
      <address>
        <city>London</city>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Ormond Street Hospital NHS</name>
      <address>
        <city>London</city>
        <zip>WC1N 3JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Israel</country>
    <country>Japan</country>
    <country>Serbia</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>December 1, 2021</last_update_submitted>
  <last_update_submitted_qc>December 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2021</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>
    <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/NCT04466306
org study id: ChildrensHA
nct id: NCT04466306
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is an observational registry of children with or suspected to have SARS CoV2
      (COVID-19) admitted to pediatric intensive care units (PICU). This registry will help
      describe the prevalence, rate and severity of acute kidney injury (AKI) in children with
      Severe Acute Respiratory Syndrome Coronavirus-2(SARS CoV2) across the world. The registry
      will be developed using a point prevalence methodology and then full retrospective review.
      Once a week, from April through June 2020, data collection will occur in "real-time" to
      estimate a weekly point prevalence of AKI and renal replacement therapy (RRT). The
      operational definition of "patients under investigation" (PUIs) will be used to identify the
      denominator of patients to be studied. The PUIs will be cohorted into SARS CoV2 test
      positive, test negative, test pending, or test unavailable. The primary aim of this study is
      to deliver a global, objective data driven analysis of the burden of AKI in virus positive
      patients or patients under investigation (PUI) who are admitted to the pediatric intensive
      care unit.
The primary purpose of the data collection will be to provide a descriptive analysis of the
      burden and characteristics of AKI in children with SARS-CoV2 proven or suspected infection
      across the world. This is a prospective, point prevalence study. Data collection will occur
      once a week during the months of April through June 2020.

      The protocol for the point prevalence is for each individual participating site to conduct a
      surveillance study on predetermined dates of their intensive care units (pediatric medical,
      surgical, cardiac ICUs) for patients by the inclusion and exclusion criteria. The study is
      strictly observational. Data will only be captured on the predetermined dates listed. The
      dates have been chosen to reflect the estimated surge and peak of the virus spread in North
      America, Europe, Africa, Asia, and Australia. The rationale for performing an urgent point
      prevalence estimation study first, includes the following: a) there is almost no knowledge on
      AKI rate, severity of AKI or how current pandemic-setting AKI phenotype differs from what we
      know of AKI in children prior to the pandemic. A rapidly-performed, high feasibility-designed
      point prevalence estimation study, with minimal data collection will provide rapid, almost
      instantaneous dissemination of results to the international community. Based on the results
      of this study, a follow-up study is planned for a full retrospective data collection of all
      viral positive patients. Understanding the burden of pediatric AKI during this pandemic
      within the current context of acute health burden in the healthcare settings and enable
      planning and feasibility evaluation for quality of care measures and potentially for upcoming
      technology needs and/or sharing of RRT technology with adult care units; b) an urgent
      point-prevalence estimation study with minimal but key data collection will inform on any
      changes to design, sample size requirements or data points for the larger granular
      longitudinal retrospective study.
observational model: Cohort
time perspective: Prospective
measure: Acute Kidney Injury (AKI)
time frame: 14 days
description: Kidney Disease Improving Global Outcomes (KDIGO) Staged AKI by serum creatinine or urine output
measure: Survival
time frame: 14 days
description: Survival to ICU discharge or Day 14
measure: Rate of Extracorporeal Therapy Requirement
time frame: 14 days
description: The use of extracorporeal membrane oxygenation (ECMO) and/or renal replacement therapy
measure: Fluid overload
time frame: Day of Enrollment
description: >20% fluid overload as defined as the net fluid balance since ICU admission (in liters) divided by ICU admission weight
measure: Rate of nephrotoxic medication exposure
time frame: Day of Enrollment
description: The exposure of enrolled patients to known nephrotoxic medications, including diuretics
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Days
maximum age: 25 Years
healthy volunteers: No
last name: Rajit K Basu, MD
role: Principal Investigator
affiliation: Children's Healthcare of Atlanta
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country: Canada
country: Israel
country: Japan
country: Serbia
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Acute Kidney Injury
mesh term: Wounds and Injuries
sharing ipd: No