Pediatric Acute Kidney Injury in COVID-19
Condition: Acute Kidney Injury; COVID
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Observational [Patient Registry]

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.
    

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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted to the pediatric medical, surgical, or cardiac ICU for any condition -
        with a suspicion for or proven diagnosis of SARS-COV2 (COVID-19).