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

NCT01987921 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5237

Last updated 2026-03-24

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Rajit K Basu, MD · Children's Hospital Medical Center, Cincinnati

  • Stuart Goldstein, MD · Children's Hospital Medical Center, Cincinnati

Eligibility

Min Age
3 Months
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States
  • Australia
  • Canada
  • China
  • Indonesia
  • Italy
  • Serbia
  • Singapore
  • South Korea
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01987921 on ClinicalTrials.gov