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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01987921
Registration number
NCT01987921
Ethics application status
Date submitted
13/11/2013
Date registered
20/11/2013
Date last updated
27/09/2016
Titles & IDs
Public title
Observational Study of Pediatric Acute Kidney Injury, Risk Factors and Outcomes
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Scientific title
Assessment of Worldwide AKI in Pediatrics, Renal Angina and Epidemiology
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Secondary ID [1]
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Pediatric AWARE Study
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Universal Trial Number (UTN)
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Trial acronym
AWARE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Kidney Injury
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Injuries and Accidents
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Other injuries and accidents
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Pediatric Intensive Care Unit Patients - All patients will be included in a single cohort initially (admission to the PICU) and then cohorted into groups based on development of severe AKI (Stage 2-3 KDIGO by either Cr or UOP criteria) within the first seven days, renal angina risk strata, medical admission diagnoses, and outcomes.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Severe AKI in first seven days of ICU Admission
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Assessment method [1]
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AKI as defined by KDIGO stage 2 or 3 (by either changes in creatinine or UOP) assessed within 7 days of ICU admission
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Timepoint [1]
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Within 7 Days of ICU admission
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Secondary outcome [1]
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AKI Conferred Risk on Mortality
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Assessment method [1]
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After adjustment for covariates, will analyze the independent conferred risk on mortality within 28 days of severe AKI (detected within the first seven days of ICU admission).
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Timepoint [1]
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28 days
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Secondary outcome [2]
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Comparison of AKI by Creatinine and Urine Output
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Assessment method [2]
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Epidemiology and AKI outcomes for patients will be separated into diagnosis by changes in creatinine, urine output, or both. Independent associations with AKI diagnosed by urine output and outcome will be identified.
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Timepoint [2]
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7 and 28 days
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Secondary outcome [3]
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Determination of AKI Progression
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Assessment method [3]
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The stage by stage increase or decrease in AKI severity will be followed - with associations determined - to identify risk factors for AKI progression to severe injury.
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Timepoint [3]
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7 days
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Secondary outcome [4]
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Identification of Predictors of Severe AKI
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Assessment method [4]
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Variables with independent associations for increased risk of severe AKI in the first seven days will be identified.
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Timepoint [4]
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7 days
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Eligibility
Key inclusion criteria
- Age greater than 90 days
- Age less than 25 years
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Minimum age
3
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Maximum age
25
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2014
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Sample size
Target
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Accrual to date
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Final
5237
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Children's Hospital at Westmead - Westmead
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Recruitment hospital [2]
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The Sydney Children's Hospitals Network - Sydney
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Recruitment postcode(s) [1]
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- Westmead
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Recruitment postcode(s) [2]
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NSW 2031 - Sydney
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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Delaware
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United States of America
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Georgia
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United States of America
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Iowa
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United States of America
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Michigan
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United States of America
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Missouri
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United States of America
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New Mexico
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United States of America
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New York
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Ohio
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Texas
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United States of America
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Virginia
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Canada
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State/province [15]
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Edmonton
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Country [16]
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Canada
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Montreal
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Canada
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Vancouver
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China
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Nanjing
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Indonesia
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Jakarta
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Indonesia
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Surabaya
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Italy
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Rome
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Korea, Republic of
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Seoul
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Serbia
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Belgrade
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Singapore
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Singapore
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Hospital Medical Center, Cincinnati
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Address
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01987921
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Rajit K Basu, MD
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Address
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Children's Hospital Medical Center, Cincinnati
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Phone
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Fax
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Email
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Contact person for public queries
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01987921
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