Use of NGAL for Fluid Dosing and CRRT Initiation in Pediatric AKI (Taking Focus 2)

March 19, 2026 updated by: Children's Hospital Medical Center, Cincinnati

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

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 Type

Observational

Enrollment (Estimated)

420

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Ohio
  - Cincinnati, Ohio, United States, 45229
    - Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 25 years (Child, Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

All critically ill patients admitted to the PICU at Cincinnati Children's Hospital Medical Center at risk for developing Acute Kidney Injury

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Decision Support Success (CDS) Time Frame: 48 hours of PICU admission	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Furosemide Stress Test (FST) Standardization Time Frame: 12 months	Validate FST in critically ill pediatric patients, with a standard dose and urinary response	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator: Stuart Goldstein, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

May 29, 2018

First Posted (Actual)

May 31, 2018

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CIN001 - Taking Focus 2
2P50DK096418-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.