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

• Conditions: Acute Kidney Injury; Renal Replacement Therapy; Pediatric Intensive Care Units

• Registration Number: NCT03541785
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

This study follows a group of patients admitted to the PICU 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 patients who will become fluid overloaded and develop 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 developed, tested, and integrated an AKI risk-stratification/clinical recognition tool (RAI) and a urine biomarker (NGAL) to try to identify patients at risk vs. not at-risk for developing AKI. However, these factors alone have yet to be integrated into clinical decision support to optimize AKI therapies and patient outcomes. The furosemide stress test (FST), previously described in adults, may be a good predictor for the patients who need acute dialysis for AKI versus those that can be managed medically.

Through this study, the investigators will be following a cohort of patients admitted to the PICU who are identified as being at risk for developing AKI through RAI and NGAL results. The aim is to standardize the FST in this population, as well as determine the accuracy of the RAI-NGAL-FST clinical decision tool in predicting patients who become fluid overloaded and develop AKI.

Study Timeline

• Study First Submitted: 2018-05-16
• Study First Submitted QC: 2018-05-29
• Study First Posted: 2018-05-31
• Study Start: 2018-07-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-25
• Primary Completion: 2026-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

• Admitted to the Pediatric Intensive Care Unit (PICU)
• Renal Angina Index (RAI) greater than or equal to 8
• Urine NGAL greater than or equal to 150 ng/mL
• Indwelling urinary catheter

Exclusion Criteria

• Evidence of volume depletion
• Baseline Chronic Kidney Disease (CKD) Stage IV or V (estimated GFR <60 mL/min/1.73m2)
• History of kidney transplantation
• Active DNR order or clinical team is not committed to escalating medical care
• Known history of allergic reaction to furosemide (only for FST)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Decision Support Success (CDS)	48 hours of PICU admission	Time to complete risk stratification (RAI), biomarker testing (NGAL), and functional kidney assessment (FST) is less than 48 hours

Secondary Outcome Measures

Name	Time	Method
Furosemide Stress Test (FST) Standardization	12 months	Validate FST in critically ill pediatric patients, with a standard dose and urinary response

Trial Locations

Locations (1)

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