Pediatric Acute Kidney Injury in COVID-19

NCT04466306 | Completed DMC

• 1 other identifier: ChildrensHA
• Study Type: observational
• Target: 400
• Locations: 7 countries
• Sites: 47

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.

Conditions

Acute Kidney Injury; COVID

Outcome Measures

Primary Outcomes (1)

• Acute Kidney Injury (AKI)

  Kidney Disease Improving Global Outcomes (KDIGO) Staged AKI by serum creatinine or urine output

  14 days

Secondary Outcomes (4)

• Survival

  14 days

• Rate of Extracorporeal Therapy Requirement

  14 days

• Fluid overload

  Day of Enrollment

• Rate of nephrotoxic medication exposure

  Day of Enrollment

Eligibility Criteria

• Age: 7 Days - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• Children's Healthcare of Atlanta: lead
• Children's Hospital Medical Center, Cincinnati: collaborator
• Children's of Alabama: collaborator
• The Hospital for Sick Children: collaborator

Study Sites (47)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

Arkansas Children's Research Institute

Little Rock, Arkansas, 72202, United States

Location

Cedars-Sinai Maxine Dunitz Children's Health Center

Los Angeles, California, 90048, United States

Location

UCLA Mattel Children's Hospital

Los Angeles, California, 90095, United States

Location

Lucile Packard Children's Hospital Standford

Palo Alto, California, 94304, United States

Location

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Yale New Haven Children's Hospital

New Haven, Connecticut, 06504, United States

Location

UF Health Shands Children's Hospital

Gainesville, Florida, 32608, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Comer Children's Hospital - UChicago Medicine

Chicago, Illinois, 60637, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

University of Iowa Stead Family Children's Hospital

Iowa City, Iowa, 52242, United States

Location

Children's Mercy

Kansas City, Kansas, 64108, United States

Location

John Hopkins Children's Center

Baltimore, Maryland, 21287, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

Location

Beaumont Children's Hospital

Royal Oak, Michigan, 48073, United States

Location

St. Louis Children's Hospital of Washington University

St Louis, Missouri, 63110, United States

Location

Oishei Children's Hospital of Buffalo

Buffalo, New York, 14203, United States

Location

Golisano Children's Hospital - University of Rochester Medicine

Rochester, New York, 14642, United States

Location

Stony Brook Children's Hospital

Stony Brook, New York, 11794, United States

Location

Levine Children's Hospital

Charlotte, North Carolina, 28203, United States

Location

Duke Children's Hospital and Health Center

Durham, North Carolina, 27705, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Penn State Children's Hospital

Hershey, Pennsylvania, 17033, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Lifespan Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina Shawn Jenkins Children's Hospital

Charleston, South Carolina, 29425, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Stollery Children's Hospital

Edmonton, Alberta, T6G 2C8, Canada

Location

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

The Hospital for Sick Children (SickKids)

Toronto, Ontario, M5G 1X8, Canada

Location

Soroka University Medical Center

Beersheba, Israel

Location

Dana-Dwek Children's Hospital

Tel Aviv, Israel

Location

Shizuoka Children's Hospital

Shizuoka, Japan

Location

Institute for Mother and Child Healthcare

Belgrade, Serbia

Location

University Children's Hospital

Belgrade, Serbia

Location

Hospital 12 de Octubre

Madrid, Spain

Location

Birmingham Children's Hospital NHS

Birmingham, B4 6NH, United Kingdom

Location

Alder Hey Children's Hospital NHS

Liverpool, United Kingdom

Location

King's College Hospital NHS

London, SE5 9RS, United Kingdom

Location

St. George's University Hospital NHS

London, SW17 0QT, United Kingdom

Location

Great Ormond Street Hospital NHS

London, WC1N 3JH, United Kingdom

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Rajit K Basu, MD

  Children's Healthcare of Atlanta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 10, 2020
• Study Start: April 15, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: December 3, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2); US (33); JP (1); ES (1); SE (2); CA (3); GB (5)