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

NCT05114057 | Withdrawn

• 1 other identifier: CIN002 - Taking Focus 3
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Kidney Injury; Acute Kidney Injury Due to Sepsis; Neonatal Sepsis

Keywords

Renal Angina Index; NGAL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of Clinical Decision Support Completion

  48 hours

Study Arms (3)

PICU Patients

OTHER

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)

CICU Patients

OTHER

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)

NICU Patients

OTHER

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)

Interventions

Renal Angina Index (RAI) OTHER

Risk-stratification tool using measures of risk and presence of injury to predict Acute Kidney Injury

CICU Patients; NICU Patients; PICU Patients

Eligibility Criteria

• Age: Up to 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Admitted to the Pediatric Intensive Care Unit (PICU), Cardiac Intensive Care Unit (CICU), or Neonatal Intensive Care Unit (NICU) at participating institution

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Neonatal Sepsis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stuart L Goldstein, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 9, 2021
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

US (1)