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

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05114057

Collaborator

(none)

1,380

Enrollment

Location

Arms

Anticipated Duration (Months)

19.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Acute Kidney Injury Due to Sepsis Neonatal Sepsis	Other: Renal Angina Index (RAI)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1380 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2027

Anticipated Study Completion Date :

Jul 1, 2028

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Clinical Decision Support Performance [Days 2-4 after ICU admission]
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)

Secondary Outcome Measures

Rate of Clinical Decision Support Completion [48 hours]
Time to complete the risk stratification and biomarker testing is less than 48 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 25 Years

Sexes Eligible for Study:

All

Accepts 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