Pediatric Acute Kidney Injury in COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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SARS-CoV2 Pediatric Acute Kidney Injury Registry and Collaborative

Conditions
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COVID, Acute Kidney Injury

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Kidney Injury (AKI) | Kidney Disease Improving Global Outcomes (KDIGO) Staged AKI by serum creatinine or urine output | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Survival to ICU discharge or Day 14 | 14 days | 
| Rate of Extracorporeal Therapy Requirement | The use of extracorporeal membrane oxygenation (ECMO) and/or renal replacement therapy | 14 days | 
| Fluid overload | >20% fluid overload as defined as the net fluid balance since ICU admission (in liters) divided by ICU admission weight | Day of Enrollment | 
| Rate of nephrotoxic medication exposure | The exposure of enrolled patients to known nephrotoxic medications, including diuretics | Day of Enrollment |