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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Acute Kidney Injury; Acute Kidney Injury Due to Sepsis; Neonatal Sepsis
• Intervention / Treatment: Other: Renal Angina Index (RAI)

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 25 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PICU Patients; Prospectively enrolled patients admitted to the PICU will be assessed by the RAI calibration for sepsis in the PICU and including additional risk factors.	Other: Renal Angina Index (RAI); Risk-stratification tool using measures of risk and presence of injury to predict Acute Kidney Injury
Other: CICU Patients; Prospectively enrolled patients admitted to the CICU will be assessed by the RAI calibration specific to the CICU, especially post cardiac bypass	Other: Renal Angina Index (RAI); Risk-stratification tool using measures of risk and presence of injury to predict Acute Kidney Injury
Other: NICU Patients; Prospectively enrolled patients admitted to the NICU will be assessed by the RAI calibration for neonatal patients with sepsis or post abdominal surgeries	Other: Renal Angina Index (RAI); Risk-stratification tool using measures of risk and presence of injury to predict Acute Kidney Injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Decision Support Performance	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)	Days 2-4 after ICU admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Clinical Decision Support Completion	Time to complete the risk stratification and biomarker testing is less than 48 hours	48 hours

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Stuart L Goldstein, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: NGAL; Renal Angina Index
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Renal Insufficiency; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Neonatal Sepsis; Acute Kidney Injury
• Other Study ID Numbers: CIN002 - Taking Focus 3

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: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No