Pediatric Acute Kidney Injury in COVID-19

Acute Kidney Injury Clinical Trial

— SPARC-1  

Official title:

SARS-CoV2 Pediatric Acute Kidney Injury Registry and Collaborative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04466306
• Other study ID #: ChildrensHA
• Status: Completed
• Start date: April 15, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: July 2021
• Source: Children's Healthcare of Atlanta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• COVID
• Wounds and Injuries

Locations

Country	Name	City	State
Canada	Stollery Children's Hospital	Edmonton	Alberta
Canada	McMaster Children's Hospital	Hamilton	Ontario
Canada	The Hospital for Sick Children (SickKids)	Toronto	Ontario
Israel	Soroka University Medical Center	Be'er Sheva
Israel	Dana-Dwek Children's Hospital	Tel Aviv
Japan	Shizuoka Children's Hospital	Shizuoka
Serbia	Institute for Mother and Child Healthcare	Belgrade
Serbia	University Children's Hospital	Belgrade
Spain	Hospital 12 de Octubre	Madrid
United Kingdom	Birmingham Children's Hospital NHS	Birmingham
United Kingdom	Alder Hey Children's Hospital NHS	Liverpool
United Kingdom	Great Ormond Street Hospital NHS	London
United Kingdom	King's College Hospital NHS	London
United Kingdom	St. George's University Hospital NHS	London
United States	C.S. Mott Children's Hospital	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	John Hopkins Children's Center	Baltimore	Maryland
United States	Children's Hospital of Alabama	Birmingham	Alabama
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Oishei Children's Hospital of Buffalo	Buffalo	New York
United States	Medical University of South Carolina Shawn Jenkins Children's Hospital	Charleston	South Carolina
United States	Levine Children's Hospital	Charlotte	North Carolina
United States	Comer Children's Hospital - UChicago Medicine	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Duke Children's Hospital and Health Center	Durham	North Carolina
United States	UF Health Shands Children's Hospital	Gainesville	Florida
United States	Helen DeVos Children's Hospital	Grand Rapids	Michigan
United States	Penn State Children's Hospital	Hershey	Pennsylvania
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	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	Yale New Haven Children's Hospital	New Haven	Connecticut
United States	Lucile Packard Children's Hospital Standford	Palo Alto	California
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	Golisano Children's Hospital - University of Rochester Medicine	Rochester	New York
United States	Beaumont Children's Hospital	Royal Oak	Michigan
United States	St. Louis Children's Hospital of Washington University	Saint Louis	Missouri
United States	Rady Children's Hospital San Diego	San Diego	California
United States	Seattle Children's Hospital	Seattle	Washington
United States	Stony Brook Children's Hospital	Stony Brook	New York

Sponsors (4)

Lead Sponsor	Collaborator
Children's Healthcare of Atlanta	Children's Hospital Medical Center, Cincinnati, Children's of Alabama, The Hospital for Sick Children

Countries where clinical trial is conducted

United States,  Canada,  Israel,  Japan,  Serbia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Kidney Injury (AKI)	Kidney Disease Improving Global Outcomes (KDIGO) Staged AKI by serum creatinine or urine output	14 days
Secondary	Survival	Survival to ICU discharge or Day 14	14 days
Secondary	Rate of Extracorporeal Therapy Requirement	The use of extracorporeal membrane oxygenation (ECMO) and/or renal replacement therapy	14 days
Secondary	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
Secondary	Rate of nephrotoxic medication exposure	The exposure of enrolled patients to known nephrotoxic medications, including diuretics	Day of Enrollment