Pediatric Acute Kidney Injury in COVID-19
- Conditions
- Acute Kidney InjuryCOVID
- Registration Number
- NCT04466306
- Lead Sponsor
- Children's Healthcare of Atlanta
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- 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)
• None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acute Kidney Injury (AKI) 14 days Kidney Disease Improving Global Outcomes (KDIGO) Staged AKI by serum creatinine or urine output
- Secondary Outcome Measures
Name Time Method 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
Survival 14 days Survival to ICU discharge or Day 14
Rate of nephrotoxic medication exposure Day of Enrollment The exposure of enrolled patients to known nephrotoxic medications, including diuretics
Rate of Extracorporeal Therapy Requirement 14 days The use of extracorporeal membrane oxygenation (ECMO) and/or renal replacement therapy
Trial Locations
- Locations (47)
Yale New Haven Children's Hospital
🇺🇸New Haven, Connecticut, United States
Stony Brook Children's Hospital
🇺🇸Stony Brook, New York, United States
University Children's Hospital
🇷🇸Belgrade, Serbia
Stollery Children's Hospital
🇨🇦Edmonton, Alberta, Canada
Levine Children's Hospital
🇺🇸Charlotte, North Carolina, United States
UF Health Shands Children's Hospital
🇺🇸Gainesville, Florida, United States
King's College Hospital NHS
🇬🇧London, United Kingdom
Golisano Children's Hospital - University of Rochester Medicine
🇺🇸Rochester, New York, United States
McMaster Children's Hospital
🇨🇦Hamilton, Ontario, Canada
Penn State Children's Hospital
🇺🇸Hershey, Pennsylvania, United States
St. Louis Children's Hospital of Washington University
🇺🇸Saint Louis, Missouri, United States
Institute for Mother and Child Healthcare
🇷🇸Belgrade, Serbia
Birmingham Children's Hospital NHS
🇬🇧Birmingham, United Kingdom
Oishei Children's Hospital of Buffalo
🇺🇸Buffalo, New York, United States
Great Ormond Street Hospital NHS
🇬🇧London, United Kingdom
Dana-Dwek Children's Hospital
🇮🇱Tel Aviv, Israel
Alder Hey Children's Hospital NHS
🇬🇧Liverpool, United Kingdom
Beaumont Children's Hospital
🇺🇸Royal Oak, Michigan, United States
St. George's University Hospital NHS
🇬🇧London, United Kingdom
Soroka University Medical Center
🇮🇱Be'er Sheva, Israel
Shizuoka Children's Hospital
🇯🇵Shizuoka, Japan
Hospital 12 de Octubre
🇪🇸Madrid, Spain
UCLA Mattel Children's Hospital
🇺🇸Los Angeles, California, United States
The Hospital for Sick Children (SickKids)
🇨🇦Toronto, Ontario, Canada
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
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
UPMC Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Rady Children's Hospital San Diego
🇺🇸San Diego, California, United States
Duke Children's Hospital and Health Center
🇺🇸Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Children's Mercy
🇺🇸Kansas City, Kansas, United States
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
Lucile Packard Children's Hospital Standford
🇺🇸Palo Alto, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
University of Iowa Stead Family Children's Hospital
🇺🇸Iowa City, Iowa, United States
C.S. Mott Children's Hospital
🇺🇸Ann Arbor, Michigan, United States
Medical University of South Carolina Shawn Jenkins Children's Hospital
🇺🇸Charleston, South Carolina, United States
Helen DeVos Children's Hospital
🇺🇸Grand Rapids, Michigan, United States
Lifespan Hasbro Children's Hospital
🇺🇸Providence, Rhode Island, United States
John Hopkins Children's Center
🇺🇸Baltimore, Maryland, United States