Clinical trial NCT04466306: Pediatric Acute Kidney Injury in COVID-19
Official title: SARS-CoV2 Pediatric Acute Kidney Injury Registry and Collaborative
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
COVID
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
Collaborators: name: Children's Hospital Medical Center, Cincinnati
name: Children's of Alabama
name: The Hospital for Sick Children
First posted: 2020-07-10
Enrollment: 400
Sex: ALL
Minimum age (years): 7
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
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).

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.

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

Primary outcomes:
measure: Acute Kidney Injury (AKI)
timeFrame: 14 days
Secondary outcomes:
measure: Survival
timeFrame: 14 days
measure: Rate of Extracorporeal Therapy Requirement
timeFrame: 14 days
measure: Fluid overload
timeFrame: Day of Enrollment
measure: Rate of nephrotoxic medication exposure
timeFrame: Day of Enrollment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Children's Research Institute
state: Arkansas
city: Los Angeles
country: United States
facility: Cedars-Sinai Maxine Dunitz Children's Health Center
state: California
city: Los Angeles
country: United States
facility: UCLA Mattel Children's Hospital
state: California
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Standford
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital San Diego
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Children's Hospital
state: Connecticut
city: Gainesville
country: United States
facility: UF Health Shands Children's Hospital
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Comer Children's Hospital - UChicago Medicine
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Stead Family Children's Hospital
state: Iowa
city: Kansas City
country: United States
facility: Children's Mercy
state: Kansas
city: Baltimore
country: United States
facility: John Hopkins Children's Center
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: C.S. Mott Children's Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Helen DeVos Children's Hospital
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Children's Hospital
state: Michigan
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital of Washington University
state: Missouri
city: Buffalo
country: United States
facility: Oishei Children's Hospital of Buffalo
state: New York
city: Rochester
country: United States
facility: Golisano Children's Hospital - University of Rochester Medicine
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Children's Hospital
state: New York
city: Charlotte
country: United States
facility: Levine Children's Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke Children's Hospital and Health Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Hershey
country: United States
facility: Penn State Children's Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
city: Providence
country: United States
facility: Lifespan Hasbro Children's Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina Shawn Jenkins Children's Hospital
state: South Carolina
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children (SickKids)
state: Ontario
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center
city: Tel Aviv
country: Israel
facility: Dana-Dwek Children's Hospital
city: Shizuoka
country: Japan
facility: Shizuoka Children's Hospital
city: Belgrade
country: Serbia
facility: Institute for Mother and Child Healthcare
city: Belgrade
country: Serbia
facility: University Children's Hospital
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital NHS
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital NHS
city: London
country: United Kingdom
facility: King's College Hospital NHS
city: London
country: United Kingdom
facility: St. George's University Hospital NHS
city: London
country: United Kingdom
facility: Great Ormond Street Hospital NHS
Study officials:
affiliation: Children's Healthcare of Atlanta
name: Rajit K Basu, MD
role: PRINCIPAL_INVESTIGATOR
References: