NCT05114057

Use of NGAL for Fluid Dosing and CRRT Initiation in Pediatric and Neonatal AKI

Use of NGAL to Optimize Fluid Dosing, CRRT Initiation and Discontinuation in Critically Ill Children and Neonates With Acute Kidney Injury

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

This study will follow patients admitted to the PICU with sepsis, NICU with sepsis or after abdominal surgery, or CICU who are identified as being at risk for developing acute kidney injury. The investigators will use risk-stratification, biomarker testing, and a functional assessment to predict children and neonates who will become fluid overloaded and develop severe acute kidney injury.

Detailed description

In the pediatric population, acute kidney injury (AKI) is commonly observed in critically ill patients. At this time, there are no standardized care pathways that begin at identifying patients at risk for developing AKI and progress through to early recognition and treatment. Through previous work, the investigators have integrated a risk-stratification tool (renal angina index or RAI) and a urine biomarker (NGAL) to try to identify PICU patients at risk versus not at-risk for developing AKI. Through this study, the investigators will tailor the RAI to the septic population in the PICU, create a new NICU RAI, and investigate the utility of the CICU specific RAI in a prospective population. Biomarker testing will be used to further risk-stratify those patients deemed at highest risk through the RAI.

Conditions

• Acute Kidney Injury
• Acute Kidney Injury Due to Sepsis
• Neonatal Sepsis

Interventions

Type	Name	Description
OTHER	Renal Angina Index (RAI)	Risk-stratification tool using measures of risk and presence of injury to predict Acute Kidney Injury

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-08-31
• Completion: 2029-07-01
• First posted: 2021-11-09
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States