Study of the Prediction of Acute Kidney Injury in Children Using Risk Stratification and Biomarkers

Acute Kidney Injury Clinical Trial

— AKI-CHERUB  

Official title:

Prospective Study of Acute Kidney Injury in Critically Ill Children Predicted by Renal Angina and Urinary Biomarkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01735162
• Other study ID #: CIN001-AKI-CHERUB
• Status: Completed
• Phase: N/A
• First received: November 12, 2012
• Last updated: February 2, 2015
• Start date: October 2012
• Est. completion date: October 2014

Study information

• Verified date: February 2015
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: October 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Minimum stay 48 hours

• Indwelling urinary catheter

Exclusion Criteria:

• History of renal disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Renal Angina

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (3)

Basu RK, Chawla LS, Wheeler DS, Goldstein SL. Renal angina: an emerging paradigm to identify children at risk for acute kidney injury. Pediatr Nephrol. 2012 Jul;27(7):1067-78. doi: 10.1007/s00467-011-2024-5. Epub 2011 Oct 20. Review. — View Citation

Goldstein SL, Chawla LS. Renal angina. Clin J Am Soc Nephrol. 2010 May;5(5):943-9. doi: 10.2215/CJN.07201009. Epub 2010 Mar 18. Review. — View Citation

Goldstein SL. Acute kidney injury biomarkers: renal angina and the need for a renal troponin I. BMC Med. 2011 Dec 21;9:135. doi: 10.1186/1741-7015-9-135. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality	Incidence of death within 60 days of ICU admission	60 day	No
Other	Renal replacement therapy	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	During ICU stay	No
Primary	Acute kidney injury	Development of AKI by KDIGO Stage 2 criteria (Creatinine > 200% baseline)	At day 3 of PICU admission	No
Secondary	PICU length of stay	Observational assessment of duration of length of stay in PICU from time of renal angina assessment	60 days	No

External Links

•   Center for Acute Care Nephrology