Observational Study of Pediatric Acute Kidney Injury, Risk Factors and Outcomes

Completed

Conditions studied: Acute Kidney Injury

In brief

Pediatric acute kidney injury (AKI) is associated with increased morbidity and mortality in critically ill patients. Currently, understanding of the epidemiology and diagnosis of AKI in children is limited by single center retrospective data and inconsistent diagnostic and stratification criteria. The hypotheses of the AWARE study is that 1) renal angina, a composite of early injury signs and risk of disease, will predict severe subsequent AKI in critically ill children and 2) the incorporation of urinary biomarkers into the renal angina scoring system will improve the prediction of the severe injury. The AWARE study is conducted to describe AKI epidemiology in a heterogeneous multinational cohort of critically ill children, characterize AKI risk factors and associated morbidity, and validate the KDIGO AKI criteria as a predictor of pediatric AKI outcomes. The multi-center, multi-national registry will create the largest ever repository of information available on AKI in children.

Key facts

Study ID: NCT01987921
Run by: Children's Hospital Medical Center, Cincinnati
People needed: 5237
Starts: 2014-01-01
Expected to finish: 2014-12-01
Last updated by the study team: 2026-03-24

Who can join

Age: 0 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age greater than 90 days
Age less than 25 years

You may not qualify if…

Patients on maintenance hemodialysis, peritoneal dialysis, or with chronic kidney disease with a baseline eGFR of <15 mL/min/1.73m2
Patients with renal transplant received less than 90 days from the ICU admission.
Patients admitted to ICU immediately post-operative to within three months following surgical correction of congenital heart disease.
Patients with uncorrected congenital heart disease. This criteria does not include patients with isolated uncorrected ventricular septal defect (VSD), atrial septal defect (ASD), patent ductus arteriosus (PDA) and patent foramen ovale (PFO).
Patients following cardiac catheterization.

Where it is running

University of Alabama — Birmingham, Alabama, United States
Stanford University — Palo Alto, California, United States
Children's Hospital Colorado — Aurora, Colorado, United States
Yale University — New Haven, Connecticut, United States
Nemours/Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
Emory University — Atlanta, Georgia, United States
University of Iowa — Des Moines, Iowa, United States
University of Michigan — Ann Arbor, Michigan, United States
Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States
Children's Mercy Hospitals and Clinics — Kansas City, Missouri, United States
Washington University in St. Louis — St Louis, Missouri, United States
University of New Mexico — Albuquerque, New Mexico, United States
Cohen Children's Medical Center of NY — New Hyde Park, New York, United States
Stony Brook Long Island Children's Hospital — Stony Brook, New York, United States
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Texas Children's Hospital — Houston, Texas, United States
University of Texas MD Anderson Cancer Center — Houston, Texas, United States
Virginia Commonwealth University — Richmond, Virginia, United States
Children's Hospital at Westmead — Westmead, New South Wales, Australia
The Sydney Children's Hospitals Network — Sydney, Australia
University of Edmonton — Edmonton, Canada
Montreal Children's/McGill — Montreal, Canada
University of British Columbia and Children's and Women's Health Center of British Columbia Branch — Vancouver, Canada
Nanjing Children's Hospital — Nanjing, China
Dept of Child Health Cipto Mangunkusumo/University of Indonesia — Jakarta, Indonesia

Full record on ClinicalTrials.gov

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