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

Cincinnati Children's Hospital Medical Center

Status: Not yet enrolling

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

Treatments: Other: Renal Angina Index (RAI)

Study type: Interventional

Funder types: Other

Identifiers

NCT05114057

CIN002 - Taking Focus 3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,380 estimated patients

Sex: All

Ages: Under 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,380 participants in 3 patient groups

PICU Patients

Other group

Description:

Prospectively enrolled patients admitted to the PICU will be assessed by the RAI calibration for sepsis in the PICU and including additional risk factors.

Treatment:

Other: Renal Angina Index (RAI)

CICU Patients

Other group

Description:

Prospectively enrolled patients admitted to the CICU will be assessed by the RAI calibration specific to the CICU, especially post cardiac bypass

Treatment:

Other: Renal Angina Index (RAI)

NICU Patients

Other group

Description:

Prospectively enrolled patients admitted to the NICU will be assessed by the RAI calibration for neonatal patients with sepsis or post abdominal surgeries

Treatment:

Other: Renal Angina Index (RAI)