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

Acute Kidney Injury Clinical Trial

— Taking Focus 2  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03541785
• Other study ID #: CIN001 - Taking Focus 2
• Secondary ID: 2P50DK096418-06
• Status: Enrolling by invitation
• Start date: July 1, 2018
• Est. completion date: June 30, 2027

Study information

• Verified date: January 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 420
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 25 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Pediatric Intensive Care Units
• Renal Replacement Therapy

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Decision Support Success (CDS)	Time to complete risk stratification (RAI), biomarker testing (NGAL), and functional kidney assessment (FST) is less than 48 hours	48 hours of PICU admission
Secondary	Furosemide Stress Test (FST) Standardization	Validate FST in critically ill pediatric patients, with a standard dose and urinary response	12 months