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NCT01987921 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Children's Hospital Medical Center, Cincinnati.

Completed
Registry status
5,237
Enrollment target

NCT01987921: Completed study, sponsored by Children's Hospital Medical Center, Cincinnati.

NCT01987921 is a clinical trial that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 5,237 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01987921 has completed, sponsored by Children's Hospital Medical Center, Cincinnati.

COMPLETED
Registry status
5,237 participants
Enrollment target

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.

Primary Outcome

AKI as defined by KDIGO stage 2 or 3 (by either changes in creatinine or UOP) assessed within 7 days of ICU admission

Trial Details

FieldValue
Enrollment Target 5,237 participants
Start Date 2014-01
Est. Completion 2014-12

What the finished NCT01987921 record still lists

NCT01987921 is an observational study that tracks outcomes without assigning an intervention. Its 5,237 participants enrollment target places it among the larger protocols in the corpus.

The record links to 0 conditions, and to 0 interventions.

NCT01987921 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01987921 about?

NCT01987921 is a clinical study titled "Observational Study of Pediatric Acute Kidney Injury, Risk Factors and Outcomes". 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. T...

What is the current status of trial NCT01987921?

This trial is currently completed. The enrollment target is 5,237 participants. The study started on 2014-01. Estimated completion is 2014-12.

Who is sponsoring clinical trial NCT01987921?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01987921, the US trial registry maintained by the National Library of Medicine. NCT01987921 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.