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

Not Applicable

Not yet recruiting

• Conditions: Acute Kidney Injury; Acute Kidney Injury Due to Sepsis; Neonatal Sepsis

• Registration Number: NCT05114057
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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.

Study Timeline

• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-10-28
• Study First Posted: 2021-11-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12
• Study Start: 2025-12-01
• Primary Completion: 2028-08-31
• Study Completion: 2029-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1380

Inclusion Criteria

• Admitted to the Pediatric Intensive Care Unit (PICU), Cardiac Intensive Care Unit (CICU), or Neonatal Intensive Care Unit (NICU) at participating institution

Exclusion Criteria

• Baseline Chronic Kidney Disease (CKD) Stage IV or V (estimated GFR <60 mL/min/1.736m2)
• History of kidney transplant within the previous 90 days
• Ongoing AKI or Acute Kidney Disease (AKD) at ICU admission requiring renal replacement therapy initiated prior to ICU admission
• Acute DNR order or clinical team is not committed to escalating medical care
• Anticipated to require intensive care for less than 48 hours

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinical Decision Support Performance	Days 2-4 after ICU admission	Accuracy of the risk stratification and biomarker testing to rule out Acute Kidney Injury at ICU Days 2-4 as measured by the negative predictive value (NPV)

Secondary Outcome Measures

Name	Time	Method
Rate of Clinical Decision Support Completion	48 hours	Time to complete the risk stratification and biomarker testing is less than 48 hours

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States