Study of the Prediction of Acute Kidney Injury in Children Using Risk Stratification and Biomarkers (AKI-CHERUB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Information provided by (Responsible Party):
Rajit Basu, MD, F.A.A.P., Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01735162
First received: November 12, 2012
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

Acute kidney injury (AKI) is a common clinical event with severe consequences. In the pediatric intensive care unit (PICU), AKI occurs in almost 10% of all patients and evidence suggests that children are dying not just with AKI, but from AKI. Unfortunately, the treatment for AKI is limited to a great extent by delayed diagnosis. Reliance on markers of kidney injury that change only when significant damage has already occurred has rendered potential therapies ineffective. For this reason, identification of new markers of AKI that change early in the course of injury is paramount. While new AKI biomarkers have been identified, their performance in the general PICU population is variable. The investigators recently proposed the concept of 'renal angina' as a way to risk stratify patients in the ICU for AKI risk. In the AKI-CHERUB study, the investigators propose to study renal angina in PICU patients alone and in combination with urinary biomarkers for AKI prediction. The investigators hypothesize that renal angina will increase the predictive precision of urinary biomarkers for AKI.


Condition
Renal Angina
Acute Kidney Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study of Acute Kidney Injury in Critically Ill Children Predicted by Renal Angina and Urinary Biomarkers

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Acute kidney injury [ Time Frame: At day 3 of PICU admission ] [ Designated as safety issue: No ]
    Development of AKI by KDIGO Stage 2 criteria (Creatinine > 200% baseline)


Secondary Outcome Measures:
  • PICU length of stay [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Observational assessment of duration of length of stay in PICU from time of renal angina assessment


Other Outcome Measures:
  • Mortality [ Time Frame: 60 day ] [ Designated as safety issue: No ]
    Incidence of death within 60 days of ICU admission

  • Renal replacement therapy [ Time Frame: During ICU stay ] [ Designated as safety issue: No ]
    We will use a dichotomization (yes/no) of whether renal replacement therapy was used in each patient until ICU discharge or death, whichever came first, followed up to 60 days


Biospecimen Retention:   Samples Without DNA

Urinary samples, intended for discard so waiver of consent obtained. Urine samples spun and frozen at -80C. Samples to be run for biomarker ELISA kits.


Estimated Enrollment: 300
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Very high risk
Very high risk PICU patients are on mechanical ventilation and at least one inotrope or vasopressor at time of admission
High Risk
High risk PICU patients have a history of transplantation (solid organ or bone marrow)
Moderate risk
Moderate risk PICU patients are all other admissions to the ICU (may have either mechanical ventilation or inotropy/vasopressor use but not both). Cannot have a history of transplant. Minimum expected stay 48 hours.

Detailed Description:

Reliance on serum creatinine and urine output for diagnosis of acute kidney injury (AKI) has limited the ability of potential therapeutic measures to be effective. The investigators' recent proposition of the renal angina construct aims to improve and expedite AKI diagnosis through use of risk stratification. An apt parallel is the profound outcome change that has been effected in acute coronary syndrome through targeted troponin measurements in patients with both risk factors and clinical symptoms of coronary ischemia. Novel AKI biomarkers will struggle to gain widespread use until their performance in patients of varying degrees of AKI risk can be balanced with their cost and availability. The investigators hypothesize risk stratification using renal angina (ANG) identifies children at-risk vs. not at-risk for AKI, focusing subsequent biomarker measurement to "rule out" AKI only in children with ANG, increasing biomarker predictive precision. This study is significant because it represents the next step in the vertical integration of AKI biomarkers into routine clinical practice to guide their use rationally. The identification of at-risk patients to guide appropriate biomarker use is high-impact because it will make implementation of preventive and supportive therapies for AKI more effective; data from this study would serve to provide the indications to the Food and Drug Administration (FDA) for biomarker use in critically ill children. The study is innovative because it is the first prospective attempt to study the predictive performance of biomarkers AKI in the PICU population using ANG stratification. The investigators will observe all children admitted to the PICU with an expected length of stay > 48 hours. Urine will be collected from these children and levels of neutrophil gelatinase associated lipocalin (NGAL), interleukin-18 (IL-18), liver-fatty acid binding protein (l-FABP), and kidney injury molecule-1 (KIM-1) will be measured. Renal angina will be assessed at time of admission. Primary outcome will be presence of AKI (as measured by Kidney Diseases Improving Global Outcome (KDIGO) Class 2 or greater) at hospital day 3.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All children admitted to a tertiary children's hospital pediatric intensive care unit with an expected length of stay > 48 hours.

Criteria

Inclusion Criteria:

  • Minimum stay 48 hours
  • Indwelling urinary catheter

Exclusion Criteria:

  • History of renal disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735162

Contacts
Contact: Rajit Basu, MD 513-636-4259 rajit.basu@cchmc.org
Contact: Stuart Goldstein, MD 513-636-2209 stuart.goldstein@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Rajit Basu, MD       rajit.basu@cchmc.org   
Contact: Stuart Goldstein, MD       stuart.goldstein@cchmc.org   
Principal Investigator: Rajit Basu, MD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Stuart Goldstein, MD Children's Hospital Medical Center, Cincinnati
  More Information

Additional Information:
Publications:
Responsible Party: Rajit Basu, MD, F.A.A.P., Director, Center for Acute Care Nephrology, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01735162     History of Changes
Other Study ID Numbers: CIN001-AKI-CHERUB
Study First Received: November 12, 2012
Last Updated: November 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Renal angina
AKI
Pediatric Intensive Care

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

ClinicalTrials.gov processed this record on October 23, 2014