Observational Study of Pediatric Acute Kidney Injury, Risk Factors and Outcomes (AWARE)
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|ClinicalTrials.gov Identifier: NCT01987921|
Recruitment Status : Completed
First Posted : November 20, 2013
Last Update Posted : September 27, 2016
|Condition or disease|
|Acute Kidney Injury|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||5237 participants|
|Target Follow-Up Duration:||28 Days|
|Official Title:||Assessment of Worldwide AKI in Pediatrics, Renal Angina and Epidemiology|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
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.
- Severe AKI in first seven days of ICU Admission [ Time Frame: Within 7 Days of ICU admission ]AKI as defined by KDIGO stage 2 or 3 (by either changes in creatinine or UOP) assessed within 7 days of ICU admission
- AKI Conferred Risk on Mortality [ Time Frame: 28 days ]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).
- Comparison of AKI by Creatinine and Urine Output [ Time Frame: 7 and 28 days ]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.
- Determination of AKI Progression [ Time Frame: 7 days ]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.
- Identification of Predictors of Severe AKI [ Time Frame: 7 days ]Variables with independent associations for increased risk of severe AKI in the first seven days will be identified.
- Increase in pre-test probability of AKI risk using the renal angina index [ Time Frame: 3-4 days ]Assessing all patients with complete data for the presence of renal angina 12 hours after admission using the renal angina index will allow for determination of the heightened prediction of Day 3 - AKI versus standard methods of severity of illness or changes in creatinine alone.
- Biomarker incorporation into renal angina index [ Time Frame: 3-4 days ]Incorporating values of measured urinary biomarkers, we will determine the additive effect on discriminatory precision for the renal angina index on prediction of Day 3 - AKI
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987921
|Principal Investigator:||Rajit K Basu, MD||Children's Hospital Medical Center, Cincinnati|
|Principal Investigator:||Stuart Goldstein, MD||Children's Hospital Medical Center, Cincinnati|