Study of the Prediction of Acute Kidney Injury in Children Using Risk Stratification and Biomarkers
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Hospital |
| Therapuetic Areas: | Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/7/2015 |
| Start Date: | October 2012 |
| End Date: | October 2014 |
| Contact: | Rajit Basu, MD |
| Email: | rajit.basu@cchmc.org |
| Phone: | 513-636-4259 |
Prospective Study of Acute Kidney Injury in Critically Ill Children Predicted by Renal Angina and Urinary Biomarkers
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.
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.
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.
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.
Inclusion Criteria:
- Minimum stay 48 hours
- Indwelling urinary catheter
Exclusion Criteria:
- History of renal disease
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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