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SPARC-1: Pediatric Acute Kidney Injury in COVID-19

Sponsor
Children's Healthcare of Atlanta (Other)
Overall Status
Completed
CT.gov ID
NCT04466306
Collaborator
Children's Hospital Medical Center, Cincinnati (Other), Children's of Alabama (Other), The Hospital for Sick Children (Other)
400
Enrollment
47
Locations
14.5
Actual Duration (Months)
8.5
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    SARS-CoV2 Pediatric Acute Kidney Injury Registry and Collaborative
    Actual Study Start Date :
    Apr 15, 2020
    Actual Primary Completion Date :
    Jul 1, 2021
    Actual Study Completion Date :
    Jul 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Acute Kidney Injury (AKI) [14 days]

      Kidney Disease Improving Global Outcomes (KDIGO) Staged AKI by serum creatinine or urine output

    Secondary Outcome Measures

    1. Survival [14 days]

      Survival to ICU discharge or Day 14

    2. Rate of Extracorporeal Therapy Requirement [14 days]

      The use of extracorporeal membrane oxygenation (ECMO) and/or renal replacement therapy

    3. Fluid overload [Day of Enrollment]

      >20% fluid overload as defined as the net fluid balance since ICU admission (in liters) divided by ICU admission weight

    4. Rate of nephrotoxic medication exposure [Day of Enrollment]

      The exposure of enrolled patients to known nephrotoxic medications, including diuretics

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Days to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patient less than or equal to 25 years of age

    • Receiving clinical care in the pediatric intensive care unit (PICU) on a study day in April - June 2020

    • Patient considered a "Person Under Investigation" and/or tested positive for SARS-CoV2 (COVID-19)

    Exclusion Criteria:

    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Alabama Birmingham Alabama United States 35233
    2 Arkansas Children's Research Institute Little Rock Arkansas United States 72202
    3 Cedars-Sinai Maxine Dunitz Children's Health Center Los Angeles California United States 90048
    4 UCLA Mattel Children's Hospital Los Angeles California United States 90095
    5 Lucile Packard Children's Hospital Standford Palo Alto California United States 94304
    6 Rady Children's Hospital San Diego San Diego California United States 92123
    7 Children's Hospital Colorado Aurora Colorado United States 80045
    8 Yale New Haven Children's Hospital New Haven Connecticut United States 06504
    9 UF Health Shands Children's Hospital Gainesville Florida United States 32608
    10 Children's Healthcare of Atlanta Atlanta Georgia United States 30322
    11 Comer Children's Hospital - UChicago Medicine Chicago Illinois United States 60637
    12 Riley Hospital for Children Indianapolis Indiana United States 46202
    13 University of Iowa Stead Family Children's Hospital Iowa City Iowa United States 52242
    14 Children's Mercy Kansas City Kansas United States 64108
    15 John Hopkins Children's Center Baltimore Maryland United States 21287
    16 Boston Children's Hospital Boston Massachusetts United States 02115
    17 C.S. Mott Children's Hospital Ann Arbor Michigan United States 48109
    18 Helen DeVos Children's Hospital Grand Rapids Michigan United States 49503
    19 Beaumont Children's Hospital Royal Oak Michigan United States 48073
    20 St. Louis Children's Hospital of Washington University Saint Louis Missouri United States 63110
    21 Oishei Children's Hospital of Buffalo Buffalo New York United States 14203
    22 Golisano Children's Hospital - University of Rochester Medicine Rochester New York United States 14642
    23 Stony Brook Children's Hospital Stony Brook New York United States 11794
    24 Levine Children's Hospital Charlotte North Carolina United States 28203
    25 Duke Children's Hospital and Health Center Durham North Carolina United States 27705
    26 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
    27 Nationwide Children's Hospital Columbus Ohio United States 43205
    28 Penn State Children's Hospital Hershey Pennsylvania United States 17033
    29 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    30 UPMC Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15224
    31 Lifespan Hasbro Children's Hospital Providence Rhode Island United States 02903
    32 Medical University of South Carolina Shawn Jenkins Children's Hospital Charleston South Carolina United States 29425
    33 Seattle Children's Hospital Seattle Washington United States 98105
    34 Stollery Children's Hospital Edmonton Alberta Canada T6G 2C8
    35 McMaster Children's Hospital Hamilton Ontario Canada L8N 3Z5
    36 The Hospital for Sick Children (SickKids) Toronto Ontario Canada M5G 1X8
    37 Soroka University Medical Center Be'er Sheva Israel
    38 Dana-Dwek Children's Hospital Tel Aviv Israel
    39 Shizuoka Children's Hospital Shizuoka Japan
    40 Institute for Mother and Child Healthcare Belgrade Serbia
    41 University Children's Hospital Belgrade Serbia
    42 Hospital 12 de Octubre Madrid Spain
    43 Birmingham Children's Hospital NHS Birmingham United Kingdom B4 6NH
    44 Alder Hey Children's Hospital NHS Liverpool United Kingdom
    45 King's College Hospital NHS London United Kingdom SE5 9RS
    46 St. George's University Hospital NHS London United Kingdom SW17 0QT
    47 Great Ormond Street Hospital NHS London United Kingdom WC1N 3JH

    Sponsors and Collaborators

    • Children's Healthcare of Atlanta
    • Children's Hospital Medical Center, Cincinnati
    • Children's of Alabama
    • The Hospital for Sick Children

    Investigators

    • Principal Investigator: Rajit K Basu, MD, Children's Healthcare of Atlanta

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Healthcare of Atlanta
    ClinicalTrials.gov Identifier:
    NCT04466306
    Other Study ID Numbers:
    • ChildrensHA
    First Posted:
    Jul 10, 2020
    Last Update Posted:
    Dec 3, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Acute Kidney Injury
    Wounds and Injuries

    Study Results

    No Results Posted as of Dec 3, 2021