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

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.

Completed
Acute Kidney Injury
COVID
Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 7 Days ~ Maximum: 25 Years
Countries
Canada
Israel
Japan
Serbia
Spain
United Kingdom
United States
Locations

Children's Hospital of Alabama
Birmingham, Alabama, United States

Arkansas Children's Research Institute
Little Rock, Arkansas, United States

Cedars-Sinai Maxine Dunitz Children's Health Center
Los Angeles, California, United States

UCLA Mattel Children's Hospital
Los Angeles, California, United States

Lucile Packard Children's Hospital Standford
Palo Alto, California, United States

Rady Children's Hospital San Diego
San Diego, California, United States

Children's Hospital Colorado
Aurora, Colorado, United States

Yale New Haven Children's Hospital
New Haven, Connecticut, United States

UF Health Shands Children's Hospital
Gainesville, Florida, United States

Children's Healthcare of Atlanta
Atlanta, Georgia, United States

Comer Children's Hospital - UChicago Medicine
Chicago, Illinois, United States

Riley Hospital for Children
Indianapolis, Indiana, United States

University of Iowa Stead Family Children's Hospital
Iowa City, Iowa, United States

Children's Mercy
Kansas City, Kansas, United States

John Hopkins Children's Center
Baltimore, Maryland, United States

Boston Children's Hospital
Boston, Massachusetts, United States

C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States

Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States

Beaumont Children's Hospital
Royal Oak, Michigan, United States

St. Louis Children's Hospital of Washington University
Saint Louis, Missouri, United States

Oishei Children's Hospital of Buffalo
Buffalo, New York, United States

Golisano Children's Hospital - University of Rochester Medicine
Rochester, New York, United States

Stony Brook Children's Hospital
Stony Brook, New York, United States

Levine Children's Hospital
Charlotte, North Carolina, United States

Duke Children's Hospital and Health Center
Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States

Nationwide Children's Hospital
Columbus, Ohio, United States

Penn State Children's Hospital
Hershey, Pennsylvania, United States

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States

UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States

Lifespan Hasbro Children's Hospital
Providence, Rhode Island, United States

Medical University of South Carolina Shawn Jenkins Children's Hospital
Charleston, South Carolina, United States

Seattle Children's Hospital
Seattle, Washington, United States

Stollery Children's Hospital
Edmonton, Alberta, Canada

McMaster Children's Hospital
Hamilton, Ontario, Canada

The Hospital for Sick Children (SickKids)
Toronto, Ontario, Canada

Soroka University Medical Center
Be'er Sheva, Israel

Dana-Dwek Children's Hospital
Tel Aviv, Israel

Shizuoka Children's Hospital
Shizuoka, Japan

Institute for Mother and Child Healthcare
Belgrade, Serbia

University Children's Hospital
Belgrade, Serbia

Hospital 12 de Octubre
Madrid, Spain

Birmingham Children's Hospital NHS
Birmingham, United Kingdom

Alder Hey Children's Hospital NHS
Liverpool, United Kingdom

King's College Hospital NHS
London, United Kingdom

St. George's University Hospital NHS
London, United Kingdom

Great Ormond Street Hospital NHS
London, United Kingdom

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

Children's Healthcare of Atlanta
NCT Number
MeSH Terms
Acute Kidney Injury
Wounds and Injuries