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

NCT01987921 | Completed DMC

• 1 other identifier: Pediatric AWARE Study
• Study Type: observational
• Target: 5,237
• Locations: 10 countries
• Sites: 32

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.

Conditions

Acute Kidney Injury

Keywords

Acute kidney injury; Pediatrics; Critical Care

Outcome Measures

Primary Outcomes (1)

• Severe AKI in first seven 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

  Within 7 Days of ICU admission

Secondary Outcomes (4)

• AKI Conferred Risk on Mortality

  28 days

• Comparison of AKI by Creatinine and Urine Output

  7 and 28 days

• Determination of AKI Progression

  7 days

• Identification of Predictors of Severe AKI

  7 days

Other Outcomes (2)

• Increase in pre-test probability of AKI risk using the renal angina index

  3-4 days

• Biomarker incorporation into renal angina index

  3-4 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 3 Months - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All medical and surgical patients admitted to the pediatric intensive care unit

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (32)

University of Alabama

Birmingham, Alabama, 35203, United States

Location

Stanford University

Palo Alto, California, 94305, United States

Location

Children's Hospital Colorado

Aurora, Colorado, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Nemours/Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Iowa

Des Moines, Iowa, 52242, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

Location

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Cohen Children's Medical Center of NY

New Hyde Park, New York, 11354, United States

Location

Stony Brook Long Island Children's Hospital

Stony Brook, New York, 11794, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

Children's Hospital at Westmead

Westmead, New South Wales, Australia

Location

The Sydney Children's Hospitals Network

Sydney, NSW 2031, Australia

Location

University of Edmonton

Edmonton, AB T6G 2R3, Canada

Location

Montreal Children's/McGill

Montreal, QC H3H 1P3, Canada

Location

University of British Columbia and Children's and Women's Health Center of British Columbia Branch

Vancouver, Canada

Location

Nanjing Children's Hospital

Nanjing, China

Location

Dept of Child Health Cipto Mangunkusumo/University of Indonesia

Jakarta, Indonesia

Location

Dept of Child Health Airlangga University/Dr. Soetomo Hospital

Surabaya, Indonesia

Location

Ospedale Pediatrico Bambino Gesu

Rome, 00165, Italy

Location

Mother and Child Health Care

Belgrade, Serbia

Location

University Children's Hospital

Belgrade, Serbia

Location

University Children's Medical Institute, National University Hospital

Singapore, Singapore

Location

Seoul National University Children's Hospital

Seoul, South Korea

Location

King's College Hospital

London, WC2R 2LS, United Kingdom

Location

Related Publications (6)

• Basu RK, Kaddourah A, Terrell T, Mottes T, Arnold P, Jacobs J, Andringa J, Goldstein SL; Prospective Pediatric AKI Research Group (ppAKI). Assessment of Worldwide Acute Kidney Injury, Renal Angina and Epidemiology in critically ill children (AWARE): study protocol for a prospective observational study. BMC Nephrol. 2015 Feb 26;16:24. doi: 10.1186/s12882-015-0016-6.

  PMID: 25882434 RESULT

• Basu RK, Kaddourah A, Terrell T, Mottes T, Arnold P, Jacobs J, Andringa J, Armor M, Hayden L, Goldstein SL. Assessment of Worldwide Acute Kidney Injury, Renal Angina and Epidemiology in Critically Ill Children (AWARE): A Prospective Study to Improve Diagnostic Precision. J Clin Trials. 2015;5(3):222. doi: 10.4172/2167-0870.1000222. Epub 2015 Apr 17.

  PMID: 26719818 RESULT

• Selewski DT, Gist KM, Basu RK, Goldstein SL, Zappitelli M, Soranno DE, Mammen C, Sutherland SM, Askenazi DJ, Ricci Z, Akcan-Arikan A, Gorga SM, Gillespie SE, Woroniecki R; Assessment of the Worldwide Acute Kidney Injury, Renal Angina and Epidemiology (AWARE) Investigators. Impact of the Magnitude and Timing of Fluid Overload on Outcomes in Critically Ill Children: A Report From the Multicenter International Assessment of Worldwide Acute Kidney Injury, Renal Angina, and Epidemiology (AWARE) Study. Crit Care Med. 2023 May 1;51(5):606-618. doi: 10.1097/CCM.0000000000005791. Epub 2023 Feb 17.

  PMID: 36821787 DERIVED

• Basu RK, Bjornstad EC, Gist KM, Starr M, Khandhar P, Chanchlani R, Krallman KA, Zappitelli M, Askenazi D, Goldstein SL; SPARC Investigators. Acute kidney injury in critically Ill children and young adults with suspected SARS-CoV2 infection. Pediatr Res. 2022 Jun;91(7):1787-1796. doi: 10.1038/s41390-021-01667-4. Epub 2021 Jul 30.

  PMID: 34331019 DERIVED

• Ayalon I, Woo JG, Basu RK, Kaddourah A, Goldstein SL, Kaplan JM; AWARE Investigators. Weight as a Risk Factor for Mortality in Critically Ill Patients. Pediatrics. 2020 Aug;146(2):e20192829. doi: 10.1542/peds.2019-2829. Epub 2020 Jul 3.

  PMID: 32620676 DERIVED

• Kaddourah A, Basu RK, Bagshaw SM, Goldstein SL; AWARE Investigators. Epidemiology of Acute Kidney Injury in Critically Ill Children and Young Adults. N Engl J Med. 2017 Jan 5;376(1):11-20. doi: 10.1056/NEJMoa1611391. Epub 2016 Nov 18.

  PMID: 27959707 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Rajit K Basu, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Stuart Goldstein, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, Center for Acute Care Nephrology

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 20, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 24, 2026

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

SE (2); ID (2); KR (1); CN (1); SG (1); US (18); IT (1); AU (2); CA (3); GB (1)