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OpenTrials
Enrolling by Invitation

NCT Number: NCT03541785

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

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.

Enrolling by Invitation

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Key information

Age range

3 month–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Furosemide Stress Test (FST) Standardization

    Time frame: 12 months

    Validate FST in critically ill pediatric patients, with a standard dose and urinary response

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Taking Focus 2

Important dates

Study start
2018
Primary completion
2028
Study completion
2029
First posted
May 31, 2018
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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