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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
Sponsor:
Information provided by (Responsible Party):
Rajit Basu, MD MS FAAP FCCM, Children's Hospital Medical Center, Cincinnati

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.

Condition or disease
Acute Kidney Injury

  Show Detailed Description

Study Type : Observational [Patient Registry]
Actual Enrollment : 5237 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Group/Cohort
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.


Other Outcome Measures:
  1. 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.

  2. 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
Urine samples will be collected from participating centers (pending local IRB approval)


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Ages Eligible for Study:   3 Months to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All medical and surgical patients admitted to the pediatric intensive care unit
Criteria

Inclusion Criteria:

  • Age greater than 90 days
  • Age less than 25 years

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.

Information from the National Library of Medicine

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


  Show 32 Study Locations
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Rajit K Basu, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Stuart Goldstein, MD Children's Hospital Medical Center, Cincinnati

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rajit Basu, MD MS FAAP FCCM, Co-Director, Center for Acute Care Nephrology, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01987921     History of Changes
Other Study ID Numbers: Pediatric AWARE Study
First Posted: November 20, 2013    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual center data will be distributed per patient/location. Sites will not receive data for patients enrolled at other sites. All data will be centrally housed at Cincinnati Children's Hospital.

Keywords provided by Rajit Basu, MD MS FAAP FCCM, Children's Hospital Medical Center, Cincinnati:
Acute kidney injury
Pediatrics
Critical Care

Additional relevant MeSH terms:
Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases