A New Study Validates NGAL as Predictor of Acute Kidney Injury in Children
An innovative study has resulted in the first-ever Food and Drug Administration (FDA) clearance for using neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker to predict acute kidney injury (AKI) in critically ill children within the first 24 hours of intensive care unit (ICU) admission. Led by Stuart Goldstein, MD, director of the Center for Acute Care Nephrology at Cincinnati Children’s, this multi-center research holds significant implications for the early detection and management of AKI in pediatric intensive care units.
Goldstein, the principal investigator for the NGAL threshold derivation and validation studies, explains the program’s goal: “We aimed to develop an optimal threshold for NGAL to predict stage 2 or 3 AKI, achieving US Food and Drug Administration clearance. And we did just that.”
The Power of Early Detection: NGAL’s Clinical Applications
The study established a 125 ng/ml cutoff for urine NGAL levels, providing clinicians with a powerful tool for risk assessment. “Where NGAL performs incredibly well is if the level is below 125 ng/ml. In this case, the likelihood of a patient having either AKI that persists to 72 hours or AKI that develops in 72 hours is very low,” Goldstein states. This allows clinicians to focus their attention on patients with elevated NGAL levels.
These patients may require further diagnostic testing or additional clinical decision support to protect their kidneys. If the kidneys don’t improve, other interventions, like initiating dialysis, may become necessary.
From Research to Practice: Implementing NGAL in Clinical Settings
Cincinnati Children’s has been implementing NGAL testing in clinical practice. Since 2016, we have integrated NGAL assessment into our protocols for high-risk patients, using it alongside the Renal Angina Index (RAI). This scoring system combines risk factors and early signs to predict severe AKI.
This approach has led to significant improvements in patient care. Goldstein explains, “Using risk stratification and NGAL in this manner, coupled with collaboration with our intensive care unit colleagues, allowed us to guide fluid management and dialysis initiation more effectively.”
As a result, Goldstein and his team have achieved several significant outcomes. These include earlier initiation of acute dialysis without increasing the number of patients receiving it. Additionally, they have seen shorter ICU stays after dialysis discontinuation. Finally, there has been an increase in survival rates for dialysis patients.
Future Directions: Paving the Way for Novel Therapies
The validation of NGAL as a predictive biomarker opens new avenues for research and treatment. Goldstein emphasized the potential for developing targeted interventions.
“NGAL, combined with risk stratification, allows us to identify a specific patient population that would benefit from potential therapeutic options. We can now design prospective studies to evaluate medications, devices and other interventions aimed at preventing acute kidney injury or mitigating its effects in these high-risk patients,” he says.
Collaboration is Key to Pediatric Nephrology Advancements
The success of this study highlights the importance of collaboration within the pediatric acute care nephrology community. Goldstein says, “We conducted two prospective multi-center studies in children during the COVID-19 pandemic, under budget and on time, and we achieved FDA approval for the first time for NGAL. NGAL has not yet received FDA clearance in adults, which speaks to our community's collaborative nature.”
This achievement marks a significant milestone in pediatric nephrology and positions Cincinnati Children’s and the Center for Acute Care Nephrology as leaders in coordinating crucial studies for children’s health worldwide.
(Published March 2026)
